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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 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.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01595529
The ClinicalTrials.gov registry entry for NCT01595529 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 717 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01595529 reports 0 study locations.
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.
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