Not Signed In -
Sulfamethoxazole |
Gantanol |
Clinical Trial: Prophylactic Antibiotics on Urethral Catheter Withdrawal
This study is currently recruiting patients.
Verified by St. Antonius Hospital July 2005
|
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 IV |
MedlinePlus related topics: Urinary Tract Infections
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Use of Antibiotic Prophylaxis on Urethral Catheter Withdrawal: A Randomized Double-Blind Placebo-Controlled Trial
Further Study Details:
Primary Outcomes: Symptomatic bacteriuria; Asymptomatic bacteriuria
Secondary Outcomes: Antibiotic resistance patterns
Expected Total Enrollment: 100
Secondary Outcomes: Antibiotic resistance patterns
Expected Total Enrollment: 100
Study start: January 2005; Expected completion: May 2006
Last follow-up: March 2006; Data entry closure: April 2006
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 above, Genders Eligible for Study: Both
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00126698
B. C. van Hees, MD +31-30-6092624 b.van.hees@antonius.net
M. Tersmette, MD, PhD +31-30-6092624 m.tersmette@antonius.net
M. Tersmette, MD, PhD +31-30-6092624 m.tersmette@antonius.net
Netherlands, Utrecht
Sint Antonius Hospital, Nieuwegein, Utrecht, 3430 EM, Netherlands; Recruiting
B. C. van Hees, MD +31-30-6092624 b.van.hees@antonius.net
M. Tersmette, MD, PhD +31-30-6092624 m.tersmette@antonius.net
B. C. van Hees, MD, Principal Investigator
M. Tersmette, MD, PhD, Principal Investigator
P. Go, MD, PhD, Principal Investigator
E. Wiltink, PhD, Principal Investigator
P. Vijverberg, MD, PhD, Sub-Investigator
L. Hoorntje, MD, PhD, Sub-Investigator
M. Tersmette, MD, PhD +31-30-6092624 m.tersmette@antonius.net
B. C. van Hees, MD, Principal Investigator
M. Tersmette, MD, PhD, Principal Investigator
P. Go, MD, PhD, Principal Investigator
E. Wiltink, PhD, Principal Investigator
P. Vijverberg, MD, PhD, Sub-Investigator
L. Hoorntje, MD, PhD, Sub-Investigator
Study chairs or principal investigators
M. Tersmette, MD, PhD, Study Director, Sint Antonius Hospital, Nieuwegein
More Information
Study ID Numbers: 2005-01; CAD-Trial
Last Updated: August 19, 2005
Record first received: August 2, 2005
ClinicalTrials.gov Identifier: NCT00126698
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-08-23
Last Updated: August 19, 2005
Record first received: August 2, 2005
ClinicalTrials.gov Identifier: NCT00126698
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-08-23
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