Short-Course Therapy for Urinary Tract Infections in Children: The SCOUT Randomized Clinical Trial

Authors

Theoklis Zaoutis
Nader Shaikh
Brian T Fisher
Susan E Coffin
Sonika Bhatnagar
Kevin J Downes
Jeffrey S Gerber
Timothy R Shope
Judith M Martin
Gysella B Muniz
Michael Green
Jennifer P Nagg
Sage R Myers
Rakesh D Mistry
Shawn O'Connor
Walter Faig
Stephen Black
Elizabeth Rowley
Kellie Liston
Alejandro Hoberman

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

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?" in JAMA Pediatr, 37358846. See the letter "Nonsuperiority of Standard Therapy Compared to Short-Course Therapy in Symptomatic UTIs." in JAMA Pediatr, 37812426.

Supplementary Materials

PMID: 37358858