The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"

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).

Timeline

Start

2012-05-18

Primary completion

2019-06-30

Completion

2019-08-12

Publications

• Zaoutis T, Shaikh N, Fisher BT, Coffin SE, Bhatnagar S, Downes KJ, Gerber JS, Shope TR, Martin JM, Muniz GB, Green M, Nagg JP, Myers SR, Mistry RD, O'Connor S, Faig W, Black S, Rowley E, Liston K, Hoberman A. Short-Course Therapy for Urinary Tract Infections in Children: The SCOUT Randomized Clinical Trial. JAMA Pediatr. 2023 Aug 1;177(8):782-789. doi: 10.1001/jamapediatrics.2023.1979.

Drugs

Indications