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NCT01450800 · ClinicalTrials.gov registry record · Phase 4
Suppressive Therapy With Oral Antibiotics for Prevention of Postoperative Urinary Tract Infection (UTI)
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 163
- Enrollment target
NCT01450800: Completed Phase 4 study, sponsored by Duke University.
NCT01450800 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 163 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01450800, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 163 participants
- Enrollment target
Study Summary
This is a study of patients undergoing gynecologic surgery who require post-operative catheterization to determine if prophylactic antibiotic treatment decreases the risk of post-operative urinary tract infection in these patients.
Primary Outcome
The primary outcome was treatment for UTI within the first 3 weeks after surgery. Treatment for UTI was defined to include any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery. Clinically suspected treatment was defined to include treatment given empirically upon development of urinary symptoms or prescribed based on urine test results. Culture-proven UTI was defined as a urine culture with greater than 100,000 colony-forming units o
Interventions
- DRUG Placebo
- DRUG Nitrofurantoin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-09 |
| Phase | Phase 4 |
What the finished NCT01450800 record still lists
NCT01450800 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01450800 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01450800 about?
NCT01450800 is a clinical study titled "Suppressive Therapy With Oral Antibiotics for Prevention of Postoperative Urinary Tract Infection (UTI)". This is a study of patients undergoing gynecologic surgery who require post-operative catheterization to determine if prophylactic antibiotic treatment decreases the risk of post-operative urinary tract infection in these patients.
What is the current status of trial NCT01450800?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 163 participants. The study started on 2011-08. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01450800?
The interventions under investigation include: Placebo (DRUG), Nitrofurantoin (DRUG).
Who is sponsoring clinical trial NCT01450800?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01450800's enrollment target sits among peer trials
163 501st of 2000 higher than 1,498 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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