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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
Est. primary completion date
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


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
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