Prevention of Nosocomial E. Coli Infections After Placement of an Indwelling Catheter During Pelvic Surgery: an Evaluation of Cranberry Gel Capsules

NCT01114347 | Completed Phase 2

• 2 other identifiers: AOI/2009/VL-012009-A01317-50
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cross Infection; Bacteriuria

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cranberry

EXPERIMENTAL

Patients randomized to this arm will recieve 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.

Dietary Supplement: cranberry type A pro anthocyandines

Placebo

PLACEBO COMPARATOR

The patients randomized to this arm will recieve 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.

Dietary Supplement: Placebo

Interventions

cranberry type A pro anthocyandines DIETARY_SUPPLEMENT

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

Cranberry

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (3)

• Letouzey V, Ulrich D, Demattei C, Alonso S, Huberlant S, Lavigne JP, de Tayrac R. Cranberry capsules to prevent nosocomial urinary tract bacteriuria after pelvic surgery: a randomised controlled trial. BJOG. 2017 May;124(6):912-917. doi: 10.1111/1471-0528.14524. Epub 2017 Feb 10.

  PMID: 28186383 RESULT

• Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.

  PMID: 37947276 DERIVED

• Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.

  PMID: 37068952 DERIVED

MeSH Terms

Conditions

Cross Infection; Bacteriuria

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urinary Tract Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Vincent Letouzey, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 3, 2010
• Study Start: August 1, 2010
• Primary Completion: March 22, 2014
• Study Completion: March 22, 2014
• Last Updated: November 17, 2025

Record last verified: 2015-03

Locations

FR (1)