Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01114347
Other study ID # AOI/2009/VL-01
Secondary ID 2008-AO1604-51
Status Completed
Phase Phase 2
First received April 30, 2010
Last updated March 25, 2015
Start date August 2010
Est. completion date March 2014

Study information

Verified date March 2015
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
Study type Interventional

Clinical Trial Summary

Indwelling urinary catheters are a primary site for nosocomial infections. The purpose of this study is to evaluate the anti-adhesive properties of Cranberry type A pro anthocyanidine gel capsules in the prevention Escherichia coli infections on indwelling urinary catheters placed in patients following pelvic surgery. The investigators primary working hypothesis is that cranberry treatment decreases E. coli colonization on indwelling urinary catheters, thus preventing nosocomial urinary infections following pelvic surgery.


Recruitment information / eligibility

Status Completed
Enrollment 270
Est. completion date March 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient is cared for by the department of the Gynecology at the Nîmes Unversity Hospital

- The patient is programmed for surgery with placement an indwelling catheter for 48 hours with a sterile urinary cytobacteriologic exam at inclusion

Exclusion Criteria:

- the urinary cytobacteriologic exam at inclusion is positive

- the patient is taking antivitamin K

- the patient is taking antibiotics

- history of urolithiasis

- the patient refuses to participate

- the patient is pregnant or nursing

- the patient is not associated with a social security system (no insurance)

- the patient is under guardianship

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
cranberry type A pro anthocyandines
One gel capsule containing cranberry PAC (36 mg of type A pro anthocyandines: Urell, Pharmatoka) per day starting at the day of the pelvic surgery (j0) until day 10 postop (j10). The gel capsule in taken orally in the morning with a large glass of water
Placebo
One placebo gel capsule per day starting on the day of the pelvic surgery (j0) until the 10th day post-op (j10). The gel capsule is taken orally in the morning with a large glass of water. The placebo contains lactose and is conditioned in a manner to be identical in caliber and color with the experimental treatment gel capsules.

Locations

Country Name City State
France CHU de Nîmes - Hôpital Universitaire Carémeau Nîmes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Presence/absence of Asymptomatic bacteriuria Presence/absence of greater than 10^5 unit forming E. coli colonies per ml of urine with absence of functional urinary infection symptoms (mictional burning, pollakiuria, dysuria, urgency, suprapubic heaviness) 15 days post-op No
See also
  Status Clinical Trial Phase
Completed NCT03131609 - Avoiding Bacterial Contamination of Clean Catch Urine Cultures in Ambulatory Patients in the Emergency Department
Withdrawn NCT04230746 - Effect of Antibiotics on Urinary Microbiome Early Phase 1
Completed NCT01143116 - Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization N/A
Enrolling by invitation NCT01349738 - Asymptomatic Bacteriuria & Risk of Urinary Tract Infection in Renal Transplants N/A
Completed NCT02922868 - Assessment of Infection Control, Practice Efficiency, and Health Economics of Sheathed Versus Standard Cystoscopy N/A
Withdrawn NCT02052674 - Retained Urine Volume and Bacteriuria in Traditional Versus Vented Urine Drainage Systems Phase 1
Completed NCT00258089 - A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Complicated Urinary Tract Infections Phase 3
Recruiting NCT04985110 - Administration of Antibiotic Prophylaxis for Transperineal Prostate Biopsy in Cipto Mangunkusumo Hospital Phase 2
Recruiting NCT02032394 - Effect of Chlorhexidine on Bacteriuria Phase 4
Withdrawn NCT03816384 - Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria N/A
Enrolling by invitation NCT00717600 - Bacteriuria Eradication Through Probiotics Phase 1
Completed NCT00126698 - Prophylactic Antibiotics on Urethral Catheter Withdrawal Phase 4
Completed NCT00258102 - A Study of the Safety and Effectiveness of Levofloxacin Compared With Lomefloxacin in the Treatment of Complicated Urinary Tract Infections Phase 3
Completed NCT02797613 - Restricted Reporting for Positive Urine Cultures N/A
Not yet recruiting NCT04658719 - A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria N/A
Completed NCT02575495 - A Randomized Control Trial of Antibiotic Treatment Duration For Asymptomatic Bacteriuria After Kidney Transplantation Phase 2
Completed NCT02277171 - Evaluation of Safety and Tolerability of Nitric Oxide Impregnated Urinary Catheters Phase 1
Completed NCT01033383 - Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents Phase 1
Completed NCT00093938 - Cranberry Juice for Preventing Bacteria in Urine During Pregnancy Phase 1
Completed NCT01691430 - A Trial of Cranberry Capsules for Urinary Tract Infection Prevention in Nursing Home Residents Phase 3