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Completed

NCT Number: NCT01691430

A Trial of Cranberry Capsules for Urinary Tract Infection Prevention in Nursing Home Residents

Urinary tract infection (UTI) is the most common infection in nursing home residents, and bacteriuria is the greatest trigger for antimicrobial therapy in the nursing home setting. The primary aim of this study is to test the efficacy of two oral cranberry capsules per day in the reduction of bacteriuria plus pyuria in female nursing home residents. These aims will be accomplished by conducting a double blind randomized placebo controlled efficacy trial of two oral cranberry capsules daily versus placebo in a cohort of Connecticut female nursing home residents.

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Key information

Conditions

Bacteriuria Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Branford Hills Health Care, Branford, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female residents;
  • long term residents
  • English speaking; and
  • age ≥ 65 years.

Exclusion criteria

  • residents that are not expected to be in the nursing home for at least one month (i.e., short term rehabilitation, pending discharge, terminal [life expectancy < 1 month]);
  • residents who are on chronic suppressive antibiotic or anti-infective (i.e., mandelamine) therapy for recurrent UTI;
  • residents with end stage renal disease on dialysis (they do not regularly produce urine);
  • residents unable to produce a baseline clean catch urine specimen for collection;
  • residents on warfarin therapy because of a potential interaction of warfarin and cranberry juice;
  • residents with a history of nephrolithiasis because cranberry may increase the risk of nephrolithiasis;
  • have an indwelling bladder catheter in place;
  • have an allergy to cranberry products;
  • are being treated with cranberry products;
  • residence <4 weeks.

Treatment and study plan

2 cranberry capsules

Dietary Supplement

Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)

Placebo

Dietary Supplement

Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)

Primary outcomes

  1. Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)

    Time frame: One year

    Clean catch urine cultures and urinalyses will be obtained every two months for each participant for study purposes.

Secondary outcomes

  1. Number of Episodes of Symptomatic UTI

    Time frame: One year

    Suspected UTI episodes that are recorded in the medical record by the primary provider will be reviewed by chart review, symptoms will be recorded, and two adjudicators will determine if the definition of symptomatic UTI is met.

  2. Number of Hospitalizations

    Time frame: One year

  3. Number of Deaths

    Time frame: One year

  4. Number of Antibiotic Prescriptions

    Time frame: One year

    Chart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant.

  5. Bacteriuria With Multidrug-resistant Gram-negative Bacilli

    Time frame: One year

    All urine culture data will be reviewed to determine presence of multidrug-resistant gram-negative bacilli (resistance to ≥3 of the following antibiotics: ampicillinsulbactam,cefazolin, ceftriaxone, ceftazidime, fluoroquinolones, piperacillin-tazobactam, meropenem, imipenem, and trimethoprim-sulfamethoxazole).

  6. Number of Antibiotic Prescriptions for Suspected UTI

    Time frame: One Year

    Chart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant's suspected UTI.

  7. Subjects With 1, 2, or 3 Episodes of UTIs

    Time frame: One year

    Suspected UTI episodes that are recorded in the medical record by the primary provider will be reviewed by chart review, symptoms will be recorded, and two adjudicators will determine if the definition of symptomatic UTI is met.

Other outcomes

  1. Number of Adverse Events in Participants

    Time frame: One year

  2. Adherence to Capsule Intake by All Participants

    Time frame: One year

    measured by capsules removed from blister packs

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

A Randomized, Controlled Trial of Cranberry Capsules for UTI Prevention in Nursing Home Residents

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 24, 2012
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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