The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"
Status:
Completed
Trial end date:
2019-08-12
Target enrollment:
Participant gender:
Summary
The SCOUT study is a multi-center, centrally randomized, double-blind, placebo-controlled
non-inferiority clinical trial. 746 participants will be enrolled over a 4.5 year period. 672
will be evaluated for the study's primary outcome measure. After the first 5 days of primary
care physician initiated antimicrobial therapy, patients who are afebrile and asymptomatic
will then be randomized (1:1) to the standard course therapy arm of 5 more days of the same
antibiotic therapy or the short course therapy arm of a placebo for 5 more days (for 10 days
total). The primary objective of this study is to determine if halting antimicrobial therapy
in subjects who have exhibited clinical improvement 5 days after starting antibiotic therapy
(short course therapy) have the same failure rate (symptomatic UTI) through visit Day 11-14
as subjects who continue to take antibiotics for an additional 5 days (standard course
therapy).
Phase:
Phase 2
Details
Lead Sponsor:
Children's Hospital of Philadelphia National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
Children's Hospital of Pittsburgh National Institute of Allergy and Infectious Diseases (NIAID) University of Pennsylvania Westat