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CompletedNCT01114347NosoPinkUpdated Nov 17, 2025

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

A Phase 2 interventional study of cranberry type A pro anthocyandines and Placebo in Cross Infection and Bacteriuria, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
270
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Cross Infection
  • Bacteriuria
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In context

Cross Infection

285 studies on the registry are indexed under Cross Infection; 48 are open to participants now.

This study's enrollment of 270 is above the median of 185 across 169 interventional studies indexed under Cross Infection.

Browse Cross Infection studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
270 participants (actual)

Study arms

  • Experimental
    Cranberry

    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 comparator
    Placebo

    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

  • Dietary supplementcranberry 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

  • Dietary supplementPlacebo

    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.

06

What researchers measure

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)

    Time frame: 15 days post-op

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Study locations

1 site
  • CHU de Nîmes - Hôpital Universitaire Carémeau
    Nîmes, 30029, France
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References and documents

Publications

  • 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. PubMed 28186383 ↗
  • 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. PubMed 37947276 ↗
  • 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. PubMed 37068952 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01114347
Responsible party
Sponsor
First posted
May 3, 2010
Start date
Aug 2010
Primary completion
Mar 22, 2014
Completion
Mar 22, 2014
Last update
Nov 17, 2025

Study contacts

Vincent Letouzey, MD
principal investigator · Centre Hospitalier Universitaire de Nīmes

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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