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Suppressive Therapy With Oral Antibiotics for Prevention of Postoperative Urinary Tract Infection (UTI)

NCT01450800 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2017-02-13

Study results available
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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.

Conditions

Interventions

DRUG

Nitrofurantoin

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Cindy Amundsen, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-03-31
Completion
2013-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01450800 on ClinicalTrials.gov