CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 163 enrolled
Drug / intervention
Nitrofurantoin +1 moredrug
Likely dose
Nitrofurantoin 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01450800
NCT01450800Phase 4Completed
CompareCT.gov

Antibiotic Prophylaxis for Urinary Tract Infection in Patients Requiring Catheterization After Urogynecologic Surgery

Duke University·interventional·Posted Oct 12, 2011·Updated Feb 13, 2017

In Brief

A Phase 4 clinical trial evaluating Nitrofurantoin and Placebo for Urinary Tract Infection. Completed, enrolled 163 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Tract Infection
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 12, 2011
Enrollment StartAug 1, 2011
Primary CompletionMar 1, 2013
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.7 years ago

Interventions

Nitrofurantoindrug

Nitrofurantoin 100mg po daily to be taken every day the patient uses a catheter for up to one week post-operatively

Placebodrug

Participants randomized to placebo will be instructed to take placebo one tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization