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- Title
Short-Course Therapy for Urinary Tract Infections in Children: The SCOUT Randomized Clinical Trial.
- Authors
Zaoutis, Theoklis; Shaikh, Nader; Fisher, Brian T.; Coffin, Susan E.; Bhatnagar, Sonika; Downes, Kevin J.; Gerber, Jeffrey S.; Shope, Timothy R.; Martin, Judith M.; Muniz, Gysella B.; Green, Michael; Nagg, Jennifer P.; Myers, Sage R.; Mistry, Rakesh D.; O'Connor, Shawn; Faig, Walter; Black, Stephen; Rowley, Elizabeth; Liston, Kellie; Hoberman, Alejandro
- Abstract
The study attempts to compare the efficacy of standard-course and short-course therapy for urinary tract infections in children 2 months to 10 years old. Key Points: Question: What is the efficacy of short-course vs standard-course therapy for children with urinary tract infection? Finding: In this randomized clinical trial of 664 children, those children assigned to standard-course therapy had lower rates of treatment failure than children assigned to short-course therapy, but the rate in both treatment groups was low. Meaning: The low failure rate in children receiving short-course therapy suggests that it could be considered as a reasonable treatment option. 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
- Subjects
PENNSYLVANIA; ANTIBIOTICS; GUT microbiome; DRUG efficacy; PATIENT aftercare; HOST-bacteria relationships; RESEARCH; CLINICAL trials; CONFIDENCE intervals; URINARY tract infections; CHILDREN'S hospitals; TREATMENT duration; BACTERIURIA; ANTI-infective agents; RANDOMIZED controlled trials; PLACEBOS; TREATMENT failure; DESCRIPTIVE statistics; RESEARCH funding; BLIND experiment; STATISTICAL sampling; URINALYSIS; DRUG resistance in microorganisms; OUTPATIENT services in hospitals; MICROBIAL sensitivity tests; EVALUATION; SYMPTOMS; CHILDREN
- Publication
JAMA Pediatrics, 2023, Vol 177, Issue 8, p782
- ISSN
2168-6203
- Publication type
Article
- DOI
10.1001/jamapediatrics.2023.1979