Febrile Infants With Urinary Tract Infections at Very Low Risk for Adverse

Events and Bacteremia

David Schnadower, Nathan Kuppermann, Charles G. Macias, Stephen B. Freedman,
Marc N. Baskin, Paul Ishimine, Camille Scribner, Pamela Okada, Heather Beach,
Blake Bulloch, Dewesh Agrawal, Mary Saunders, Donna M. Sutherland, Mercedes M.
Blackstone, Amit Sarnaik, Julie McManemy, Alison Brent, Jonathan Bennett, Jennifer
M. Plymale, Patrick Solari, Deborah J. Mann, Peter S. Dayan and for the American
Academy of Pediatrics Pediatric Emergency Medicine Collaborative Research
Committee
Pediatrics 2010;126;1074-1083; originally published online Nov 22, 2010;
DOI: 10.1542/peds.2010-0479

The online version of this article, along with updated information and services, is
located on the World Wide Web at:
http://www.pediatrics.org/cgi/content/full/126/6/1074

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Febrile Infants With Urinary Tract Infections at Very
Low Risk for Adverse Events and Bacteremia
WHAT’S KNOWN ON THIS SUBJECT: Febrile infants aged 29 to 60
days who have urinary tract infections are typically hospitalized
for ⱖ48 hours. Previous study results have indicated that most
patients have benign clinical courses, but small sample sizes
have limited the ability to identify those at near-zero risk of
adverse events.
WHAT THIS STUDY ADDS: We derived prediction models in a
large sample of patients that identify infants at very low risk for
adverse events and at low risk for bacteremia. Shorter
hospitalization or outpatient treatment with close follow-up may
be feasible for selected patients.
abstract
BACKGROUND: There is limited evidence from which to derive guide-
lines for the management of febrile infants aged 29 to 60 days with
urinary tract infections (UTIs). Most such infants are hospitalized for
ⱖ48 hours. Our objective was to derive clinical prediction models to
identify febrile infants with UTIs at very low risk of adverse events and
bacteremia in a large sample of patients.
METHODS: This study was a 20-center retrospective review of infants
aged 29 to 60 days with temperatures of ⱖ38°C and culture-proven
UTIs. We defined UTI by growth of ⱖ50 000 colony-forming units
(CFU)/mL of a single pathogen or ⱖ10 000 CFU/mL in association with
positive urinalyses. We defined adverse events as death, shock, bacte-
rial meningitis, ICU admission need for ventilator support, or other
substantial complications. We performed binary recursive partitioning
analyses to derive prediction models.
RESULTS: We analyzed 1895 patients. Adverse events occurred in 51 of
1842 (2.8% [95% confidence interval (CI): 2.1%–3.6%)] and bacteremia
in 123 of 1877 (6.5% [95% CI: 5.5%–7.7%]). Patients were at very low risk
for adverse events if not clinically ill on emergency department (ED)
examination and did not have a high-risk past medical history (predic-
tion model sensitivity: 98.0% [95% CI: 88.2%–99.9%]). Patients were at
lower risk for bacteremia if they were not clinically ill on ED examina-
tion, did not have a high-risk past medical history, had a peripheral
band count of ⬍1250 cells per ␮L, and had a peripheral absolute
neutrophil count of ⱖ1500 cells per ␮L (sensitivity 77.2% [95% CI:
68.6%– 84.1%]).
CONCLUSION: Brief hospitalization or outpatient management with
close follow-up may be considered for infants with UTIs at very low risk
of adverse events. Pediatrics 2010;126:1074–1083
1074 SCHNADOWER et al
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AUTHORS: David Schnadower, MD, MPH,a Nathan
Kuppermann, MD, MPH,b Charles G. Macias, MD, MPH,c
Stephen B. Freedman, MD,d Marc N. Baskin, MD,e Paul
Ishimine, MD,f Camille Scribner, MD,g Pamela Okada, MD,h
Heather Beach, MD,i Blake Bulloch, MD,j Dewesh Agrawal,
MD,k Mary Saunders, MD,l Donna M. Sutherland, MD,m
Mercedes M. Blackstone, MD,n Amit Sarnaik, MD,o Julie
McManemy, MD,p Alison Brent, MD,q Jonathan Bennett,
MD,r Jennifer M. Plymale, MDb Patrick Solari, MD,s
Deborah J. Mann, MD,t and Peter S. Dayan, MD, MSca for
the American Academy of Pediatrics Pediatric Emergency
Medicine Collaborative Research Committee
aPediatric Emergency Medicine, Morgan Stanley Children’s
Hospital of New York, Columbia University College of Physicians
and Surgeons, New York, New York; bEmergency Medicine and
Pediatrics, University of California, Davis School of Medicine,
Sacramento, California; cPediatric Emergency Medicine, Texas
Children’s Hospital, Baylor College of Medicine, Houston, Texas;
dPaediatric Emergency Medicine and Gastroenterology,
Hepatology and Nutrition, Hospital for Sick Children, University
of Toronto, Toronto, Ontario, Canada; ePediatrics, Children’s
Hospital Boston and Harvard Medical School, Boston,
Massachusetts; fDepartment of Medicine, Rady Children’s
Hospital, University of California, San Diego, California;
gPediatric Emergency Medicine, Children’s Hospital Oakland,
Oakland, California; hPediatric Emergency Medicine, Children’s
Medical Center, University of Texas Southwestern Medical
Center, Dallas, Texas; iPediatric Emergency Medicine, Miami
Children’s Hospital, Miami, Florida; jPediatric Emergency
Medicine, Phoenix Children’s Hospital, University of Arizona
College of Medicine, Phoenix, Arizona; kPediatric Emergency
Medicine, Children’s National Medical Center, George
Washington School of Medicine, Washington, District of
Columbia; lPediatric Emergency Medicine, Children’s Hospital of
Wisconsin, Medical College of Wisconsin, Milwaukee, Wisconsin;
mPediatric Emergency Medicine, Wake Med Health, Raleigh,
North Carolina; nPediatric Emergency Medicine, Children’s
Hospital of Philadelphia, University of Pennsylvania School of
Medicine, Philadelphia, Pennsylvania; oPediatric Emergency
Medicine, Children’s Hospital of Michigan, Wayne State
University, Detroit, Michigan; pPediatric Emergency Medicine, St
Louis Children’s Hospital, Washington University School of
Medicine, St Louis, Missouri; qPediatric Emergency Medicine,
Children’s Hospital, University of Colorado School of Medicine,
Denver, Colorado; rPediatric Emergency Medicine, A. I. duPont
Hospital for Children, Thomas Jefferson University, Jefferson
Medical College, Wilmington, Delaware; sPediatric Emergency
Medicine, Children’s Hospital and Regional Medical Center,
University of Washington School of Medicine, Seattle,
Washington; and tEmergency Medicine, State University of New
York, Upstate, Syracuse, New York
(Continued on last page)

Urinary tract infection (UTI) is the most
common serious bacterial illness in fe-
brile infants younger than 60 days of
age, occurring in 4% to 10% of these
infants.1– 6 In 1999, an American Acad-
emy of Pediatrics guideline recom-
mended outpatient management with
oral or parenteral antibiotics for chil-
dren older than 2 months who have
UTIs unless the child seemed “toxic, de-
hydrated, or unable to take oral in-
take,” in which case hospitalization
was recommended.7 There is little in-
formation however, to guide the man-
agement of infants aged 29 to 60
days.8,9 Although a recent clinical trial
found it feasible to treat febrile infants
with UTIs as outpatients with paren-
teral antibiotics administered in an in-
fusion center,8 most clinicians hospi-
talize these infants for ⱖ48 hours of
parenteral therapy.10–12
There are several reasons why clini-
cians hospitalize infants aged 29 to 60
days of age who have UTIs, including
the unclear risk of long-term renal in-
jury, and concern regarding follow-up.
The most important reasons, however,
are the concerns of acute adverse
events and for missing concomitant
bacteremia. Several small studies
have assessed the course of febrile in-
fants with UTIs and suggest that other-
wise well-appearing infants with or
without concomitant bacteremia have
benign clinical courses when treated
with appropriate antibiotics.9–13 Be-
cause of small sample sizes, investiga-
tors have neither been able to provide
a precise estimate of the risk of ad-
verse events or bacteremia nor derive
potential multivariable models to iden-
tify risk factors for adverse events or
bacteremia in young, febrile infants
with UTIs.
The aims of this study were to deter-
mine the risk of adverse events and
bacteremia in a large sample of febrile
infants aged 29 to 60 days with UTIs
who present to the emergency depart-
PEDIATRICS Volume 126, Number 6, December 2010
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ment (ED), and to derive clinical pre-
diction models for infants at very low
risk of adverse events and bacteremia.
These data may help clinicians make
more informed decisions regarding
the need for, or length of hospitaliza-
tion of these infants.
METHODS
Study Design and Setting
We performed a retrospective chart
review at 20 medical centers that par-
ticipated in the Pediatric Emergency
Medicine Collaborative Research Com-
mittee of the American Academy of Pe-
diatrics. The participating centers in-
cluded 16 tertiary care pediatric EDs
and 3 general EDs in the United States
and 1 Canadian tertiary care ED. Ap-
proval for the study with waiver of in-
formed consent and for data sharing
with the coordinating institution and
with the centralized data center was
granted by the institutional review
board at each participating institution.
Patient Identification
We performed case ascertainment by
querying laboratory databases for all
urine cultures with bacterial growth in
patients aged 29 to 60 days that were
obtained in the ED between January
1995 and May 2006. Lactobacillus, Mi-
crococcus, diptheroids, Bacillus spe-
cies and Staphylococcus epidermidis
were considered contaminants.
Inclusion Criteria
Children were classified as having a
UTI if urine cultures grew a single
pathogen and colony counts met at
least 1 of 3 criteria:
1. ⱖ1000 colony-forming units (CFU)/mL
for urine cultures obtained by su-
prapubic aspiration;
2. ⱖ50 000 CFU/mL from a catheter-
ized specimen; or
3. ⱖ10 000 and ⬍50 000 CFU/mL from
a catheterized specimen in asso-
ARTICLES
ciation with positive urinalysis
results.14
We defined positive urinalysis results
as those that met any of the following:
(a) any organisms visualized on Gram-
stain; (b) trace or greater result for
leukocyte esterase or nitrite on ED dip-
stick or laboratory-based urinalysis;
or (c) ⱖ5 white blood cells (WBCs) per
high-power field (standard micros-
copy) or per ␮L (hemocytometer) on a
centrifuged or uncentrifuged urine
specimen.15–17
Exclusion Criteria
We excluded patients for any of the fol-
lowing: (a) transfer from other hospi-
tals with previously obtained labora-
tory results; (b) urine specimens
obtained by techniques other than su-
prapubic aspiration or transurethral
catheterization; (c) urine cultures that
grew multiple organisms; or (d) no
measured temperature of ⱖ38.0°C in
the ED or at home within 24 hours of ED
presentation. We excluded patients
without a measured fever because we
were interested in patients with a high
likelihood of true UTIs, not those with
asymptomatic bacteriuria.
Data Collection and Potential Risk
Factors
All coinvestigators were trained by the
study’s principal investigator in per-
son or during conference calls. Each of
the coinvestigators reviewed the med-
ical charts for all study patients at
their site. Study data were entered
onto computerized PDF documents
(“teleforms”) (Adobe Acrobat 8 Profes-
sional, San Jose, CA) that were pro-
grammed to improve data accuracy
and completeness. The teleforms were
then uploaded electronically or by fax
into a central database to avoid sec-
ondary transcription errors.
We collected data on patient demo-
graphics, past medical history, pre-
senting symptoms in the ED (including
1075
upper-respiratory infection symp-
toms, vomiting, diarrhea, difficulty
feeding, and presence of seizures), vi-
tal signs at triage, ED physical exami-
nation findings (general appearance,
dehydration, and respiratory dis-
tress), and ED disposition. We obtained
data regarding ED and inpatient man-
agement and the patient’s clinical
course, radiologic study results, as
well as urine, blood, and cerebrospinal
fluid (CSF) laboratory and microbiol-
ogy results.
We also assessed for the presence of
acute concomitant diseases defined as
an acute, focal infectious process dis-
tinct from the UTI, such as pneumonia,
bronchiolitis, cellulitis, osteomyelitis, or
septic arthritis. We did not consider
acute gastroenteritis or acute otitis me-
dia as an acute concomitant disease.
A priori, we created the variable “clin-
ically ill in the ED,” defined as an infant
who was judged as ill-appearing, dehy-
drated, or in respiratory distress or
who had an acute concomitant disease
diagnosed in the ED. We also created
the variable “high risk past medical
history,” which included a history of
genitourinary abnormalities, previous
UTIs, bacteremia, meningitis, previous
laboratory evaluation for fever, prema-
turity (⬍37 weeks’ gestation), or his-
tory of a severe systemic disease
(complex heart, chronic lung, meta-
bolic, or neurologic diseases). Other
past medical history such as minor
neonatal complications, jaundice, gas-
troesophageal reflux or a history of a
minor resolved acute illness was not
considered to represent a high-risk
past medical history (coded “not high
risk”).
Outcome Measures
We had 2 study outcomes: adverse
events and bacteremia. Although the
occurrence of an adverse event was
considered the most clinically impor-
tant outcome, we also included bacte-
1076 SCHNADOWER et al
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remia because it is clinically relevant
even in the absence of an adverse
event.
An adverse event was considered
present if any of the following oc-
curred: death, shock, bacterial menin-
gitis, ICU or step-down ICU admission
or transfer (for ICU or step-down ICU
level of care and monitoring), need for
ventilatory support (intubation, contin-
uous, or bilevel positive airway pres-
sure), need for surgical intervention,
or other substantial clinical complica-
tion. Patients did not meet this defini-
tion if the adverse event was solely re-
lated to an iatrogenic complication
(eg, anaphylaxis because of a medica-
tion, nosocomial infection).
We defined shock as (a) “shock”
clearly stated in a faculty or fellow phy-
sician note, (b) use of vasopressors, or
(c) the combination of low blood pres-
sure (⬍70 mm Hg systolic) or “hypo-
tension” or “sepsis” clearly stated in
medical chart (“rule out sepsis” did
not qualify as sepsis) and the patient
was treated with intravenous fluid bo-
luses of ⱖ40 mL/kg.
To provide a conservative risk esti-
mate,18–20 we defined bacterial menin-
gitis as definite or probable and in-
cluded all cases in the analysis:
1. We defined definite bacterial menin-
gitis as the growth of a known
pathogen in the CSF. Bacillus spe-
cies, Propionibacterium acnes,
non–Staphylococcus aureus, and
Streptococcus viridans were con-
sidered contaminants.
2. For patients with no bacterial
growth in the CSF cultures, we de-
fined probable bacterial meningitis
as any of the following:
● the combination of (a) CSF pleo-
cytosis (ⱖ10 cells per ␮L) and
(b) positive blood culture and (c)
treatment consistent with bacte-
rial meningitis (defined as ⱖ14
days of parenteral antibiotics not
clearly administered for other
reasons on review of inpatient
records); or
● the combination of (a) positive
CSF Gram-stain or positive latex
agglutination tests and (b) treat-
ment consistent with bacterial
meningitis; or
● the combination of (a) pretreat-
ment with antibiotics before lum-
bar puncture, (b) CSF pleocytosis
(ⱖ10 cells per ␮L), and (c) treat-
ment consistent with bacterial
meningitis.
Bacteremia was defined as the growth of
a pathogen in the blood culture. We con-
sidered blood cultures that grew Bacil-
lus species, Propionibacterium acnes,
or non–S aureus as contaminated.
Data Validity and Reliability
Subjective Physical Examination
Variables
To minimize the potential bias associ-
ated with abstracting physical exami-
nation findings from the medical chart,
we used specific, restrictive key words
to determine and assign whether the
infant was ill-appearing, dehydrated,
or in respiratory distress (see Appen-
dix). To determine inter-rater reliabil-
ity, a second assessor at each institu-
tion performed an independent
assessment of the documented physi-
cal examination for a random sample
of 10% of patients as well as all pa-
tients who had bacteremia or evidence
of adverse events.
Determination of Adverse Events
To achieve agreement on the presence
and timing of adverse events, a second
investigator at each institution inde-
pendently reviewed the medical charts
of all patients who potentially had ad-
verse events. For these patients, both
site investigators assessed (a) the na-
ture of the adverse events and (b) the
time points at which the adverse
events were identified.
 ARTICLES

Missing Data 2477 patients aged 29–60 d with

bacterial growth from urine cultures
We labeled unavailable data as miss- obtained in ED

ing except for particular presenting

symptoms (upper-respiratory infec-
582 patients excluded
tion symptoms, vomiting, difficulty ⋅ 253 no measured temperature > 38.0° C
⋅ 243 multiple organisms noted in urine culture
feeding, diarrhea, and seizures), for ⋅ 58 transferred from another facility
which the absence of a specific de- ⋅ 28 specimens not obtained by
catheterization or suprapubic aspiration
scription in the chart was interpreted
as “not present.”

Patients Discharged Home

From the ED 1895 febrile infants with UTIs analyzed

For these patients, investigators com-

pleted a detailed chart review of all
subsequent visits to the hospital
within 1 year of the ED visit at which the 176 discharged home from ED (9.3%) 1719 hospitalized (90.7%)
UTI was diagnosed. If there were sub- General inpatient service: 1632 (94.9%)
sequent visits but no documentation of ICU or step-down ICU: 37 (2.1%)
Transferred to outside hospital: 50 (2.9%)
adverse events that occurred during
the UTI illness, we categorized the out-
come as uncomplicated. If there were
no subsequent visits documented
Adverse events: 0/146a (0%) Adverse events: 51/1696a (3.0%)
within the year, we categorized the Bacteremia: 6/176 (3.4%) Bacteremia: 117/1701a (6.9%)
outcome as unknown.

Statistical Analysis FIGURE 1

We described the risk of adverse
events and bacteremia as proportions
with 95% confidence intervals (CIs).
The unweighted Cohen’s ␬ value was
used to determine the interrater reli-
ability for the assessor review of sub-
jective physical examination findings.
Prediction Models for Adverse
Events and Bacteremia
We performed 2 separate binary re-
cursive partitioning analyses to iden-
tify a group of infants at very low risk
for adverse events and a group of in-
fants at very low risk for bacteremia. In
these analyses, we included all the fol-
lowing potential predictor variables
with biological plausibility for associa-
tion with the outcome variables: age;
past medical history; history of feeding
difficulty; vomiting; seizures; clinical
appearance in the ED; presence of
acute concomitant disease; vital signs
at triage; peripheral WBC count; pe-
ripheral blood absolute neutrophil
Study flow. a Of those with known outcomes.
count (ANC); peripheral blood band
count; peripheral blood immature/to-
tal neutrophil ratio; and CSF WBC
count. Continuous variables were di-
chotomized and rounded by analyzing
frequency distributions, receiver oper-
ating curves, and single-variable re-
cursive partitioning analyses to iden-
tify the best predictive and clinically
sensible cutoff points for association
with each of the 2 outcomes.
Because our aim was to identify which
patients were at very low risk of the 2
outcomes, we assigned a high relative
cost to misclassification of patients
with adverse events or bacteremia. We
assigned a relative cost of 100 to 1 for
failure to identify a patient with an ad-
verse event versus incorrect classifi-
cation of a patient without an adverse
event, and a cost of 20 to 1 for failure to
identify a patient with bacteremia ver-
sus incorrect classification of a patient
without bacteremia. We used “Gini”
splitting rules and pruned the result-
ing trees to improve simplicity and
generalizability. Finally, we used 10-
fold cross-validation to develop robust
and generalizable prediction models.
We report test characteristics for each
outcome and 95% CIs, calculated with
exact methods. We used Classification
and Regression Tree software (CART 6
[Salford Systems, San Diego, CA]) to
conduct the recursive partitioning
analyses. Finally, we performed bivari-
ate and multivariate regression analy-
ses (using SPSS 16 [SPSS Inc, Chicago,
IL]) for variables included in the pre-
diction models to assess the strength
of association of these variables with
the 2 outcomes.
Sample Size
We based our sample size on the ability
to provide precise estimates of the

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risk of adverse events, the risk of bac- TABLE 1 Patient Characteristics and Laboratory Results (N ⫽ 1895)
teremia, and the sensitivities of the Age, median (interquartile range), d 45 (37–52)
prediction models. In a sample of 1500 Male, n/N (%)a 1200/1895 (63.3)
Circumcised 90/834 (10.8)
infants aged 29 to 60 days with fever Race, n/N (%)
and UTIs, we expected the upper ends White 907/1355 (66.9)
of the 95% CIs for an assumed 2% esti- Black 236/1355 (17.4)
Asian 109/1355 (8.0)
mated risk of adverse events and 5% Other 103/1355 (7.6)
estimated risk of bacteremia to be Hispanic ethnicity, n/N (%) 839/1468 (57.1)
2.8% and 6%, respectively. Given these Past medical history, n/N (%)
risk assumptions, we required ⬃50 None 1415/1882 (75.2)
Not high riskb 137/1882 (7.2)
patients with adverse events and 100 High riskc 331/1882 (17.6)
patients with bacteremia to result in a Symptoms, n/N (%)
95% CI lower boundary of 94% for a Upper respiratory illness symptoms 720/1895 (38.0)
Feeding difficulties 705/1895 (37.2)
model to predict adverse events that Vomiting 404/1895 (21.3)
was 100% sensitive, and a lower bound- Diarrhea 232/1895 (12.2)
ary of 89% for a model to predict bacte- Decreased urine output 117/1895 (6.2)
Seizure 20/1895 (1.0)
remia that was 95% sensitive. Previous Measured temperature at home ⱖ 38.0°C, n/N (%) 1525/1895 (80.5)
literature suggested we were unlikely to Fever duration at home (includes tactile), n/N (%)
derive a model that was 100% sensitive ⬍24 h 1208/1584 (76.3)
24–47 h 234/1584 (14.8)
to detect bacteremia.12,13
48–72 h 101/1584 (6.4)
⬎72 h 41/1584 (2.6)
RESULTS Maximum temperature in ED, mean (SD) 38.8°C (0.6)
The information from 1 of the 20 par- Temperature ⱖ 38.0°C in ED, n/N (%) 1876/1895 (99.0)
Physical examination
ticipating institutions was excluded Ill-appearing, n/N (%); ␬d 256/1852 (13.8); 0.81
because of systematically missing Dehydrated, n/N (%); ␬d 122/1832 (6.7); 0.78
data. The remaining institutions had Respiratory distress, n/N (%); ␬d 96/1840 (5.2); 0.86
Acute concomitant disease, n/N (%) 25/1895 (1.3)
access to microbiology databases dat- Clinically ill in ED (any of the above), n/N (%) 391/1859 (21.0)
ing 3 to 10 years. We identified 2477 General laboratory results, n/N (%)
potentially eligible patients, of whom Positive urinalysis 1762/1862 (94.6)
Peripheral blood
1895 were included in the analysis (Fig 1).
WBC count, mean cells ⫻ 103/␮L (SD) 14.6 (6.6)
WBC count ⱖ 15 cells ⫻ 103/␮L, n/N (%) 834/1864 (44.7)
Patient Characteristics Cerebrospinal fluid
The demographics, clinical character- Lumbar puncture performed 1609/1895 (84.9)
WBC count, median (interquartile range) cells per ␮Le 4 (1–8)
istics, and general laboratory results WBC count ⱖ 10 WBCs per ␮Le 295/1609 (18.3)
of our population are summarized in Urine microbiology results, n/N (%)
Table 1. Most patients had no signifi- Escherichia coli 1630/1895 (86.0)
Klebsiella sp. 108/1895 (5.7)
cant past medical histories, were fe- Enterobacter sp. 53/1895 (2.8)
brile for ⬍24 hours, and were well- Enterococcus sp. 37/1895 (1.9)
appearing. Escherichia coli was the Citrobacter sp. 21/1895 (1.1)
Group B Streptococcus 17/1895 (0.9)
predominant organism in the urine.
Proteus sp. 10/1895 (0.5)
Most patients were hospitalized and Pseudomonas sp. 8/1895 (0.4)
treated with parenteral antibiotics, Staphylococcus aureus 6/1895 (0.3)
with a median length of hospitalization Other 5/1895 (0.3)
Urine pathogen sensitive to ceftriaxone, n/N (%) 1447/1458 (99.2)
of 3 days (interquartile range: 2–5 Blood microbiology results
days). Positive blood culture, n/N (%) 123/1877 (6.5)
E coli 108/123 (87.8)
Risk of Adverse Events Enterococcus 5/123 (4.1)
Enterobacter 4/123 (3.2)
Adverse events occurred in 51 of 1842 S aureus 2/123 (1.6)
infants for whom outcome data were Pseudomonas, Group B Streptococcus, Klebsiella, Proteus 1/123 each (0.8)
Treated with parenteral antibiotics, n/N (%) 1810/1895 (95.5)
available (2.8% [95% CI: 2.1%–3.6%])
Median duration (interquartile range), d 4 (3–5)
(Table 2). Adverse events were diag-

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TABLE 1 Continued
Duration of fever (of those hospitalized), n/N (%)
⬍24 h
24–47 h
48–72 h
⬎72 h
Febrile on discharge
a Denominators are the numbers of patients for whom data points were available.
b
Not high-risk past medical history was defined as minor neonatal complications, jaundice, gastroesophageal reflux
disease, or minor resolved acute illness.
c High-risk past medical history was defined as genitourinary abnormalities, previous UTI, bacteremia, meningitis, previous
laboratory evaluation for fever, prematurity (⬍37 weeks’ gestation), or severe systemic disease (complex heart, chronic
lung, metabolic, or neurological diseases).
d Cohen’s unweighted ␬ (interrater reliability).
e Corrected CSF WBC was defined as WBC ⫺ red blood cells/500.
TABLE 2 Likelihood of Adverse Events in Infants Aged 29 to 60 Days With UTI and Fever (N ⫽ 51)
Adverse Event
Death
Shock
Bacterial meningitis (definite or probable)b
Definite bacterial meningitis
Other
ICU/step-down ICU admission
Need for ventilatory support
Need for surgery
Other complicationsc
a Several patients met multiple criteria for adverse events.
b For those with CSF obtained.
c Includes seizures, coagulopathy, congestive heart failure, cyanotic spells, renal tubular acidosis, septic hip, and severe
electrolyte abnormalities.
nosed immediately in the ED in 26 of 51
(51.0%) patients, within 4 hours of ED
presentation in 10 of 51 (19.6%), be-
tween 4 and 23 hours in 11 of 51
(21.6%), between 24 and 47 hours in 2
of 51 (3.9%), and after ⱖ48 hours in 2
of 51 (3.9%).
Risk of Bacteremia
Bacteremia was present in 123 of 1877
infants from whom blood cultures
were obtained (6.5% [95% CI: 5.5% of
7.7%]) (Table 1). The time from obtain-
ing the blood culture to the time that
the blood culture was noted to be pos-
itive was available for 91 of 123 pa-
tients (74%). The median time to posi-
tivity was 16 hours (interquartile
range: 13–24 hours); 80 of 91 (88%)
were positive within 24 hours. Ten of
123 patients with bacteremia had
adverse events (8.1% [95% CI: 4.2%–
13.8%]), whereas 41 of 1754 patients
without bacteremia had adverse
events (2.3% [95% CI: 1.7%–3.1%).
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1306/1653 (79.0)
255/1653 (15.4)
72/1653 (4.3)
12/1653 (0.7)
8/1653 (0.5)
Total, n/Na
2/1842
8/1842
5/1609
2/1609
37/1842
12/1842
4/1842
11/1842
Prediction Models for Adverse
Events and Bacteremia
Adverse Events
Recursive partitioning analysis identi-
fied a group of patients at very low risk
of adverse events (Fig 2). Patients be-
longed to the very low risk group if they
were not clinically ill on ED examina-
tion (well-appearing, not dehydrated,
not in respiratory distress, and no con-
comitant acute disease) and did not
have a high-risk past medical history.
The prediction model sensitivity for ad-
verse events was 98.0% (95% CI:
88.2%–99.9%), and the negative pre-
dictive value was 99.9% (95% CI:
99.5%–100%). Of 1206 infants in the
very low risk group (65.5% of those an-
alyzed), only 1 infant had an adverse
event (0.1% [95% CI: 0%– 0.4%]): a 46-
day-old boy who was well-appearing
on physical examination in the ED but
whose initial CSF studies were lost. A
subsequent lumbar puncture 24 hours
ARTICLES
after the initiation of intravenous anti-
biotics revealed a negative Gram-stain,
34 WBCs per ␮L, 177 red blood cells
per ␮L, 54 mg of glucose per dL, 85 mg
of protein per dL, negative bacterial
culture, and negative CSF bacterial an-
tigens. In accordance with subspecial-
ist recommendations, the infant was
treated for 21 days with intravenous
antibiotics for possible pretreated
bacterial meningitis. The patient did
not have bacteremia and had an other-
wise uneventful hospital course.
Bacteremia
% (95% CI)
0.1 (0–0.3) The recursive partitioning analysis
0.4 (0.2–0.8) identified patients to be at low risk for
0.3 (0.1–0.7) bacteremia if they met all of the follow-
0.1 (0–0.4)
ing criteria: not clinically ill in the ED,
2.0 (1.4–2.7) no high risk past medical history, a pe-
0.6 (0.3–1.1) ripheral band cell count of ⬍1250 cells
0.2 (0.1–0.5)
0.6 (0.3–1.0)
per ␮L, and a peripheral ANC of ⱖ1500
cells per ␮L (Fig 3). The prediction
model sensitivity was 77.2% (95% CI:
68.6%– 84.1%), and the negative
predictive value was 96.8% (95%
CI: 95.3%–97.8%). Bacteremia was
present in 28 of 862 patients (3.2%
[95% CI: 2.2%– 4.6%]) who met all the
low risk criteria. None of these 28 low-
risk infants had an adverse event.
Finally, Tables 3 and 4 demonstrate the
unadjusted and adjusted odds ratios
for predictor variables in the 2 analy-
ses. The presence of clinical illness in
the ED was the variable most strongly
associated with adverse events,
whereas total peripheral band count
ⱖ1250 cells per ␮L and peripheral
ANC of ⬍1500 cells per ␮L were most
highly associated with bacteremia.
DISCUSSION
In this large multicenter study, we de-
rived a clinically sensible and parsimo-
nious prediction model that identifies
a group of infants aged 29 to 60 days
with fever and UTIs who are at very low
risk of developing adverse events
when treated with antibiotics. The
model accurately predicts with very
1079
 All infants with UTIs with could be managed less conservatively
known outcome
N = 1842
than commonly practiced. Possible
strategies for managing these infants
51/1842 AE (2.8%) include hospitalization for short peri-
1791/1842 no AE (97.2%)
ods of time (eg, 24 hours) or perhaps
discharge with close follow-up to a re-
liable home environment after appro-
Clinically ill in the ED?a
priate antibiotic therapy is initiated
and the patient has a period of obser-
No Yes
vation in the ED. In the present study,
11/ 1460 AE (0.8%) 40/382 AE (10.5%) approximately two-thirds of the in-
1449/1460 no AE (99.2%) 342/382 no AE (89.5%)
fants met the low risk criteria for ad-
verse events. Investigators recently
showed that outpatient intravenous
High-risk PMH?b
antibiotic treatment in an infusion cen-
ter was feasible and safe in low risk
No Yes
infants with UTIs. That study, however,
1/1206 AE (0.1%) 10/254 AE (3.9%)
1205/1206 no AE (99.9%) 244/254 no AE (96.1%) included only 25 patients aged 29 to 60
days.8 In our series, 176 patients (9.3%
of our study population) were dis-
charged home from the ED after receiv-
AE No AE Total ing parenteral ceftriaxone without any
Any predictor present 50 586 636
No predictor present 1 1205 1206 known subsequent complications, in-
Total 51 1791 1842 cluding patients later found to have bac-
teremia. A shorter hospitalization or out-
Test characteristics of prediction model
Sensitivity: 98.0% (95 CI: 88.2–99.9) patient therapy would decrease the
Specificity: 67.3% (95% CI: 65.1–69.5) exposure of these infants to the potential
NPV: 99.9% (95% CI: 99.5–100)
iatrogenic complications associated
PPV: 7.9% (95% CI: 5.9–10.3)
LR negative: 0.03 (95% CI: 0.00–0.20) with hospitalization.21
FIGURE 2 We recognize that clinicians may be
Prediction model to identify infants aged 29 to 60 days with febrile UTIs at very low risk of adverse unwilling to discharge home from the
events. a Clinically ill in the ED, defined as ill-appearing, dehydrated, or in respiratory distress or
presence of an acute concomitant disease diagnosed in the ED; b high-risk past medical history, ED febrile infants with UTIs who poten-
defined as genitourinary abnormalities, previous UTI, bacteremia, meningitis, previous laboratory tially have bacteremia, even if they are
evaluation for fever, prematurity (⬍37 weeks’ gestation), or severe systemic disease (complex heart,
chronic lung, metabolic, or neurologic diseases). AE indicates adverse event; PMH, past medical likely to have otherwise uncomplicated
history; NPV, negative predictive value; PPV, positive predictive value; LR, likelihood ratio. clinical courses. In our series, 6.5% of
patients had bacteremia, whereas pre-
vious study estimates range from 0%
high negative predictive value that in- cated. Although we are aware of no to 21%.9,10,12,22–24 Similar to previous lit-
fants who are not clinically ill in the ED similar studies to derive models to erature, most patients in our study
and have no high-risk past medical his- predict adverse events in this popula- who had positive blood cultures were
tory will have benign clinical courses. tion, the overall low risk of adverse identified within the first 24 hours.25
The model was highly sensitive, mis- events that we found is similar to that We attempted but were unsuccessful
classifying only 1 patient (0.1%) with in small previous studies of infants in deriving a very low risk model to
an adverse event. This patient’s ad- with UTIs.8,10,12,13 identify infants with bacteremia. This
verse event (bacterial meningitis) reflects the limitations in predicting
could be questioned because the CSF Our data suggest that infants with UTIs bacteremia with standard clinical and
studies obtained in the ED were lost, and fever who meet very low risk crite- laboratory data.12,13 The addition of a
the subsequent CSF findings were un- ria for adverse events (ie, those who peripheral band count of ⬍1250 cells
likely to represent bacterial illness, are not clinically ill in the ED and have per ␮L and peripheral ANC of ⱖ1500
and his clinical course was uncompli- no high-risk past medical history) cells per ␮L to those predictors that

1080 SCHNADOWER et al
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 ARTICLES

All infants with UTIs with a accurately identify infants at very low
blood culture performed
N = 1877 risk for adverse events did decrease
the likelihood of bacteremia to 3.2%.
123/1877 bacteremia (6.6%) Previous research has noted an asso-
1754/1877 no bacteremia (93.4%)
ciation between high peripheral band
counts or low peripheral ANC with
Clinically ill in the ED?a bacteremia caused by Gram-negative
No Yes organisms.12,23,26,27
87/1488 bacteremia (5.8%) 36/389 bacteremia (9.3%) Our study had several limitations typi-
1401/1488 no bacteremia (94.2%) 353/389 no bacteremia (90.7%)
cal of medical chart reviews. These in-
cluded potential biases in data ab-
High-risk PMH?b straction, particularly of subjective
No Yes
clinical findings. We attempted to min-
65/1237 bacteremia (5.3%) 22/251 bacteremia (8.8%)
imize these biases by creating a de-
1172/1237 no bacteremia (94.7%) 229/251 no bacteremia (91.2%) tailed manual of operations that in-
cluded specific key words to interpret
subjective findings, by conducting in-
Bands >1250 cells per µL?
terrater reliability analyses of subjec-
No Yes tive variables, and by using more ob-
31/900 bacteremia (3.4%) 34/337 bacteremia (10.1%) jective criteria to define adverse
869/900 no bacteremia (96.6%) 303/337 no bacteremia (89.9%)
events. These efforts would not ac-
count for clinician documentation bi-
ANC <1500 cells per µL? ased by previous knowledge of labora-
No Yes tory results or clinical course.
28/862 bacteremia (3.2%) 3/38 bacteremia (7.9%) However, clinicians in the ED would be
834/862 no bacteremia (96.8%) 35/38 no bacteremia (92.1%) unlikely to know of future clinical dete-
rioration before initial documentation
Bacteremia No Bacteremia Total in the medical chart.
Any predictor 95 920 1015
present
We were also challenged to define bac-
No predictor present 28 834 862 terial meningitis for patients with neg-
Total 123 1754 1877 ative CSF cultures. We used conserva-
Test characteristics of prediction model tive definitions for probable bacterial
Sensitivity: 77.2% (95% CI: 68.6-84.1%) meningitis to avoid missing patients
Specificity: 47.6% (95% CI: 45.2-50.0%)
NPV: 96.8% (95% CI: 95.3-97.8%) with this important outcome. It should
PPV: 9.4% (95% Cl: 7.7-11.4%) also be recognized that we queried mi-
LR negative: 0.48 (95% Cl: 0.34, 0.66)
crobiology databases rather than at-
FIGURE 3
Prediction model to identify infants aged 29 to 60 days with febrile UTIs at low risk of bacteremia.
tempting to identify patients who pre-
a Clinically ill in the ED, defined as ill-appearing, dehydrated, or in respiratory distress or presence of sented to the ED with positive
an acute concomitant disease diagnosed in the ED; b high-risk past medical history, defined as urinalyses, which was not feasible.
genitourinary abnormalities, previous UTI, bacteremia, meningitis, previous laboratory evaluation for
fever, prematurity (⬍37 weeks’ gestation), or severe systemic disease (complex heart, chronic lung, Therefore, our results are applicable
metabolic, or neurologic diseases). PMH indicates past medical history. to those patients for whom urine cul-
ture results are known and cannot
necessarily be extrapolated to those
for whom only preliminary screening
TABLE 3 Bivariate and Multivariate Adjusted Odds Ratios for Predictors of Adverse Events in the tests for UTI are known.
Recursive Partitioning Analysis
Variable Unadjusted Odds P Adjusted Odds Ratio P CONCLUSIONS
Ratio (95% CI) (95% CI)
Clinically ill in ED 15.5 (7.8–30.4) ⬍.001 15.6 (7.9–30.9) ⬍.001 We derived a highly accurate predic-
High-risk past medical 4.0 (2.3–7.1) ⬍.001 4.3 (2.4–7.8) ⬍.001 tion model that identifies a group of
history febrile infants aged 29 to 60 days with

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TABLE 4 Bivariate and Multivariate Adjusted Odds Ratios for Predictors of Bacteremia in the
Recursive Partitioning Analysis
Variable Unadjusted Odds
Ratio (95% CI)
Clinically ill in ED 1.6 (1.1–2.4)
High-risk past medical 1.7 (1.1–2.6)
history
Peripheral bands at 2.7 (1.8–4.2)
ⱖ1250 cells per ␮L
Peripheral ANC of 3.0 (1.5–5.8)
⬍1500 cells per ␮L
UTIs at very low risk for adverse
events. We attempted but were unsuc-
cessful in deriving a very low risk
model to identify infants who had bac-
teremia. Initiating antimicrobial ther-
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 ARTICLES

APPENDIX Keywords Used by Site Assessors to Determine Physical Examination Variables

Variable Definition
Appearance
Well “Well appearing,” “no apparent distress,” “alert,” “normal mental status,” “interactive,” “smiling”
Ill “Sick,” “toxic,” “shocky,” “decreased mental status,” “lethargic,” “unresponsive,” “irritable,” “fussy,” “inconsolable,” “not looking well,”
“meningitic,” “positive Kernig,” “positive Brudzinski,” “stiff neck,” “petechial rash,” “poor or decreased perfusion,” “decreased
pulses”
Dehydration
Yes “Dry appearing,” “dry mucous membranes,” “tented skin,” “sunken eyes,” “sunken fontanelle”
No “Well hydrated,” “not dehydrated,” “presence of tears,” “moist mucous membranes,” “anterior fontanelle flat,” “well perfused”
Respiratory distress
Yes Respiratory rate ⱖ 80 breaths per min, “retractions,” “pulling,” “nasal flaring,” “increased respiratory effort,” “difficulty breathing,”
“grunting”
No “Breathing comfortably,” “calm breathing,” “normal respiratory effort”

(Continued from first page)

KEY WORDS
urinary tract infections, infants, bacteremia, meningitis, emergency department, hospitalization, outpatient therapy
ABBREVIATIONS
UTI—urinary tract infection
ED—emergency department
CFU—colony-forming unit(s)
WBC—white blood cell
CSF—cerebrospinal fluid
CI—confidence interval
ANC—absolute neutrophil count
This work was presented at the annual meetings of the American Academy of Pediatrics National Conference and Exhibition; October 10, 2008; Boston, MA; and
October 16, 2009; Washington, DC.
www.pediatrics.org/cgi/doi/10.1542/peds.2010-0479
doi:10.1542/peds.2010-0479
Accepted for publication Aug 16, 2010
Address correspondence to David Schnadower, MD, MPH, Division of Pediatric Emergency Medicine, Washington University School of Medicine, 660 S Euclid Ave,
Campus Box 8116, St. Louis, MO 63130. E-mail: schnadower_d@kids.wustl.edu
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).
Copyright © 2010 by the American Academy of Pediatrics
FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.

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 Febrile Infants With Urinary Tract Infections at Very Low Risk for Adverse
Events and Bacteremia
David Schnadower, Nathan Kuppermann, Charles G. Macias, Stephen B. Freedman,
Marc N. Baskin, Paul Ishimine, Camille Scribner, Pamela Okada, Heather Beach,
Blake Bulloch, Dewesh Agrawal, Mary Saunders, Donna M. Sutherland, Mercedes M.
Blackstone, Amit Sarnaik, Julie McManemy, Alison Brent, Jonathan Bennett, Jennifer
M. Plymale, Patrick Solari, Deborah J. Mann, Peter S. Dayan and for the American
Academy of Pediatrics Pediatric Emergency Medicine Collaborative Research
Committee
Pediatrics 2010;126;1074-1083; originally published online Nov 22, 2010;
DOI: 10.1542/peds.2010-0479
Updated Information including high-resolution figures, can be found at:
& Services http://www.pediatrics.org/cgi/content/full/126/6/1074
References This article cites 22 articles, 14 of which you can access for free
at:
http://www.pediatrics.org/cgi/content/full/126/6/1074#BIBL
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