Faculty, Staff and Student Publications
Publication Date
8-1-2023
Journal
JAMA Pediatrics
Abstract
IMPORTANCE: There is a paucity of pediatric-specific comparative data to guide duration of therapy recommendations in children with urinary tract infection (UTI).
OBJECTIVE: To compare the efficacy of standard-course and short-course therapy for children with UTI.
DESIGN, SETTING, PARTICIPANTS: The Short Course Therapy for Urinary Tract Infections (SCOUT) randomized clinical noninferiority trial took place at outpatient clinics and emergency departments at 2 children's hospitals from May 2012, through, August 2019. Data were analyzed from January 2020, through, February 2023. Participants included children aged 2 months to 10 years with UTI exhibiting clinical improvement after 5 days of antimicrobials.
INTERVENTION: Another 5 days of antimicrobials (standard-course therapy) or 5 days of placebo (short-course therapy).
MAIN OUTCOME MEASURES: The primary outcome, treatment failure, was defined as symptomatic UTI at or before the first follow-up visit (day 11 to 14). Secondary outcomes included UTI after the first follow-up visit, asymptomatic bacteriuria, positive urine culture, and gastrointestinal colonization with resistant organisms.
RESULTS: Analysis for the primary outcome included 664 randomized children (639 female [96%]; median age, 4 years). Among children evaluable for the primary outcome, 2 of 328 assigned to standard-course (0.6%) and 14 of 336 assigned to short-course (4.2%) had a treatment failure (absolute difference of 3.6% with upper bound 95% CI of 5.5.%). Children receiving short-course therapy were more likely to have asymptomatic bacteriuria or a positive urine culture at or by the first follow-up visit. There were no differences between groups in rates of UTI after the first follow-up visit, incidence of adverse events, or incidence of gastrointestinal colonization with resistant organisms.
CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, children assigned to standard-course therapy had lower rates of treatment failure than children assigned to short-course therapy. However, the low failure rate of short-course therapy suggests that it could be considered as a reasonable option for children exhibiting clinical improvement after 5 days of antimicrobial treatment.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01595529.
Keywords
Child, Humans, Female, Child, Preschool, Duration of Therapy, Anti-Bacterial Agents, Bacteriuria, Urinary Tract Infections, Treatment Outcome
DOI
10.1001/jamapediatrics.2023.1979
PMID
37358858
PMCID
PMC10294016
PubMedCentral® Posted Date
June 2023
PubMedCentral® Full Text Version
Post-print
Published Open-Access
yes
Included in
Bioinformatics Commons, Biomedical Informatics Commons, Diseases Commons, Medical Sciences Commons, Pediatrics Commons, Urology Commons
Comments
This article has been corrected. See JAMA Pediatr. 2024 April 15; 178(6): 630.
See commentary "Does the SCOUT Trial Fall Short of Determining an Effective Treatment Duration for Pediatric Urinary Tract Infections?" with doi: 10.1001/jamapediatrics.2023.1976.
See the letter "Nonsuperiority of Standard Therapy Compared to Short-Course Therapy in Symptomatic UTIs." with doi: 10.1001/jamapediatrics.2023.4056.