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Prophylactic Antibiotics on Urethral Catheter Withdrawal

This study has been completed.
Sponsor:
Information provided by:
St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT00126698
First received: August 2, 2005
Last updated: April 18, 2007
Last verified: April 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Urinary Tract Infection
Bacteriuria
 Drug: trimethoprim-sulfamethoxazole
Drug: ciprofloxacin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Use of Antibiotic Prophylaxis on Urethral Catheter Withdrawal: A Randomized Double-Blind Placebo-Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Antonius Hospital:

Primary Outcome Measures:
  • Symptomatic bacteriuria
  • Asymptomatic bacteriuria

Secondary Outcome Measures:
  • Antibiotic resistance patterns

Estimated Enrollment: 100
Study Start Date: January 2005
Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126698

Locations
Netherlands
Sint Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3430 EM
Sponsors and Collaborators
St. Antonius Hospital
Investigators
Study Director: M. Tersmette, MD, PhD Sint Antonius Hospital, Nieuwegein
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00126698     History of Changes
Other Study ID Numbers: 2005-01, CAD-Trial
Study First Received: August 2, 2005
Last Updated: April 18, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by St. Antonius Hospital:
Bacteriuria
Urinary Catheter
Urinary tract infection
Prophylaxis
Urinary catheter removal

Additional relevant MeSH terms:
Bacteriuria
Urinary Tract Infections
Infection
Urologic Diseases
Anti-Bacterial Agents
Ciprofloxacin
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on May 23, 2013