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Short-Course Therapy for Urinary Tract Infections in Children: The SCOUT Randomized Clinical Trial
Theoklis Zaoutis1, Nader Shaikh2, Brian T Fisher1
1Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Children's Hospital of Philadelphia, Philadelphia.
Insights
Standard-course therapy for pediatric urinary tract infections (UTI) showed lower treatment failure rates than short-course therapy. However, short-course therapy may be a viable option for children with UTI who improve after 5 days of antimicrobials.
Area of Science:
- Pediatric infectious diseases
- Antimicrobial stewardship
- Clinical trial methodology
Background:
- Limited pediatric-specific data exists for optimal urinary tract infection (UTI) treatment duration.
- Current guidelines often lack comparative efficacy data for varying antimicrobial therapy lengths in children.
Purpose of the Study:
- To compare the efficacy of standard-course (10 days) versus short-course (5 days) antimicrobial therapy for pediatric UTI.
- To evaluate treatment failure and secondary outcomes in children with UTI receiving different therapy durations.
Main Methods:
- A randomized clinical noninferiority trial (SCOUT) involving children aged 2 months to 10 years with UTI.
- Participants received either 5 additional days of antimicrobials (standard) or 5 days of placebo (short) after initial 5-day treatment.
- Primary outcome was symptomatic UTI at first follow-up (day 11-14); secondary outcomes included later UTI, positive cultures, and resistant organism colonization.
Main Results:
- Treatment failure occurred in 0.6% of the standard-course group vs. 4.2% of the short-course group.
- Children on short-course therapy had higher rates of asymptomatic bacteriuria or positive urine culture.
- No significant differences were observed in post-first follow-up UTI rates, adverse events, or resistant organism colonization.
Conclusions:
- Standard-course antimicrobial therapy demonstrated a lower rate of treatment failure compared to short-course therapy in pediatric UTI.
- Short-course therapy, with its low failure rate, may be a reasonable consideration for children with UTI who show clinical improvement after 5 days of treatment.
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.
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