Catheter-Associated Urinary Tract Infection Clinical Trial
— PRECAUTIONOfficial title:
Prevention of Catheter-Associated Urinary Tract Infections in Patients Undergoing Incontinence and Reconstructive Pelvic Surgery: A Randomized Controlled Trial
Verified date | October 2017 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study will assess the risk of catheter associated urinary tract infection in women undergoing incontinence or reconstructive pelvic surgery. Women will be given an antibiotic or placebo at the time of catheter removal. The investigators hypothesize that prophylactic antibiotics will reduce the rate of infection.
Status | Terminated |
Enrollment | 52 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - Requires catheterization >24h hours following incontinence or pelvic reconstructive surgery Exclusion Criteria: - Receipt of antibiotics for either prophylaxis or treatment of a known infection during the postoperative hospitalization - Allergy to sulfonamides or trimethoprim - Non-English speaking - Pregnancy - Breast feeding - Severe renal impairment (creatinine clearance <30) - Patients taking dofetilide, methenamine, procaine, warfarin, procainamide, methotrexate. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic | American Urogynecologic Society |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Urinary Tract Infection | Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as >100,000 colony forming units/mL | 7 days following catheter removal |
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