Prophylactic Antibiotics on Urethral Catheter Withdrawal

Urinary Tract Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00126698
• Other study ID #: 2005-01
• Secondary ID: CAD-Trial
• Status: Completed
• Phase: Phase 4
• First received: August 2, 2005
• Last updated: April 18, 2007
• Start date: January 2005
• Est. completion date: April 2007

Study information

• Verified date: April 2007
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacteriuria
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• trimethoprim-sulfamethoxazole

• ciprofloxacin

Locations

Country	Name	City	State
Netherlands	Sint Antonius Hospital	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic bacteriuria
Primary	Asymptomatic bacteriuria
Secondary	Antibiotic resistance patterns