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NCT01595529 · ClinicalTrials.gov registry record · Phase 2
The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 717
- Enrollment target
NCT01595529: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01595529 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 717 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (439% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01595529, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 717 participants
- Enrollment target
Study 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).
Primary Outcome
A subject will be categorized as a treatment failure, if he/she has a symptomatic UTI in period between Day 6 through the Day 11 - 14 Test of Cure (TOC) Visit: 1. Symptoms * Symptoms for all subjects (ages two months to 10 years): fever (a documented temperature of at least 100.4 °F OR 38°C measured anywhere on the body) ,dysuria * Additional symptoms for subjects \> 2 years of age: suprapubic, abdominal, or flank pain or tenderness OR urinary urgency, frequency, or hesitancy (defined as
Interventions
- OTHER Placebo
- DRUG Cephalexin
- DRUG Cefixime
- DRUG Trimethoprim/Sulfamethoxazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 717 participants |
| Start Date | 2012-05-18 |
| Est. Completion | 2019-08-12 |
| Phase | Phase 2 |
What the finished NCT01595529 record still lists
NCT01595529 is an interventional study that assigns participants to a tested intervention. The registered 717 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (439% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01595529 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01595529 about?
NCT01595529 is a clinical study titled "The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"". 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 initiate...
What is the current status of trial NCT01595529?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 717 participants. The study started on 2012-05-18. Estimated completion is 2019-08-12.
What interventions are being tested in trial NCT01595529?
The interventions under investigation include: Placebo (OTHER), Cephalexin (DRUG), Cefixime (DRUG), Trimethoprim/Sulfamethoxazole (DRUG).
Who is sponsoring clinical trial NCT01595529?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01595529's enrollment target sits among peer trials
717 45th of 2000 higher than 1,956 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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