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Prophylactic Antibiotics on Urethral Catheter Withdrawal

Primary Purpose

Urinary Tract Infection, Bacteriuria

Status

Completed

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

trimethoprim-sulfamethoxazole

ciprofloxacin

About this trial

This is an interventional prevention trial for Urinary Tract Infection focused on measuring Bacteriuria, Urinary Catheter, Urinary tract infection, Prophylaxis, Urinary catheter removal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Urethral catheter in situ for at least 3 days (72h) Exclusion Criteria: Pregnancy Impaired renal or hepatic function (serum creatinine > 150 mmol/l, serum transaminases > 75 IU/l) Fever Symptomatic urinary tract infection Antibiotic use ≤ 48 hours before urinary catheter removal Allergy to trimethoprim-sulfamethoxazole or ciprofloxacin Urologic pathology

Sites / Locations

Sint Antonius Hospital

Outcomes

Primary Outcome Measures

Symptomatic bacteriuria

Asymptomatic bacteriuria

Secondary Outcome Measures

Antibiotic resistance patterns

Full Information

NCT ID

NCT00126698

First Posted

August 2, 2005

Last Updated

April 18, 2007

Sponsor

St. Antonius Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00126698

Brief Title

Prophylactic Antibiotics on Urethral Catheter Withdrawal

Official Title

Use of Antibiotic Prophylaxis on Urethral Catheter Withdrawal: A Randomized Double-Blind Placebo-Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

St. Antonius Hospital

4. Oversight

5. Study Description

Brief Summary

Urinary-tract infection (UTI) is the most common type of hospital-acquired infection (30% of all). The purpose of this study is to determine whether antibiotic prophylaxis for urinary catheter removal is useful at preventing catheter-associated urinary-tract infection.

Detailed Description

Urinary-tract infection (UTI) is the most common type of hospital-acquired infection (30% of all). The researchers undertake a double-blind, placebo-controlled trial to assess the efficacy of single-dose therapy of trimethoprim-sulfamethoxazole or ciprofloxacin, versus placebo therapy in selected groups of surgical patients who had bladder drainage scheduled to last longer than 3 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Tract Infection, Bacteriuria

Keywords

Bacteriuria, Urinary Catheter, Urinary tract infection, Prophylaxis, Urinary catheter removal

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

trimethoprim-sulfamethoxazole

Intervention Type

Drug

Intervention Name(s)

ciprofloxacin

Primary Outcome Measure Information:

Title

Symptomatic bacteriuria

Title

Asymptomatic bacteriuria

Secondary Outcome Measure Information:

Title

Antibiotic resistance patterns

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

M. Tersmette, MD, PhD

Organizational Affiliation

Sint Antonius Hospital, Nieuwegein

Official's Role

Study Director

Facility Information:

Facility Name

Sint Antonius Hospital

City

Nieuwegein

State/Province

Utrecht

ZIP/Postal Code

3430 EM

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

Prophylactic Antibiotics on Urethral Catheter Withdrawal

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