Prevention of Catheter-Associated Urinary Tract Infection in Incontinence and Reconstructive Pelvic Surgery Patients

NCT01108757 | Terminated Results

• 1 other identifier: 10-125
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Catheter-Associated Urinary Tract Infection

Keywords

catheter; urinary tract infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Drug

EXPERIMENTAL

Drug: Bactrim

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Bactrim DRUG

Bactrim DS BID for 3 days

Drug

Placebo OTHER

Corn starch capsules

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Requires catheterization \>24h hours following incontinence or pelvic reconstructive surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• American Urogynecologic Society: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Lynn Borzi
• Organization: Cleveland Clinic

borzil@ccf.org

2164453158

Study Officials

• Matthew D Barber, MD MHS

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 22, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 18, 2017
• Results First Posted: October 18, 2017

Record last verified: 2017-10

Locations

US (1)