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

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ClinicalTrials.gov Identifier: NCT01691430
Recruitment Status : Completed
First Posted : September 24, 2012
Results First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bacteriuria Dietary Supplement: 2 cranberry capsules Dietary Supplement: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants were randomized to cranberry or placebo capsules.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Controlled Trial of Cranberry Capsules for UTI Prevention in Nursing Home Residents
Study Start Date : August 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 2 cranberry capsules
Experimental: 2 cranberry capsules
Dietary Supplement: 2 cranberry capsules
Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)

Placebo Comparator: 2 placebo capsules
Experimental: 2 placebo capsules qd
Dietary Supplement: Placebo
Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. female residents;
  2. long term residents
  3. English speaking; and
  4. age ≥ 65 years.

Exclusion Criteria:

  1. 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]);
  2. residents who are on chronic suppressive antibiotic or anti-infective (i.e., mandelamine) therapy for recurrent UTI;
  3. residents with end stage renal disease on dialysis (they do not regularly produce urine);
  4. residents unable to produce a baseline clean catch urine specimen for collection;
  5. residents on warfarin therapy because of a potential interaction of warfarin and cranberry juice;
  6. residents with a history of nephrolithiasis because cranberry may increase the risk of nephrolithiasis;
  7. have an indwelling bladder catheter in place;
  8. have an allergy to cranberry products;
  9. are being treated with cranberry products;
  10. residence <4 weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691430


Locations
United States, Connecticut
Branford Hills Health Care
Branford, Connecticut, United States, 06405
Northbridge Health Care Center
Bridgeport, Connecticut, United States, 06606
Bridgeport Health Care Center
Bridgeport, Connecticut, United States, 06610
Bridgeport Manor
Bridgeport, Connecticut, United States, 06610
Riverside Health & Rehabilitation Center
East Hartford, Connecticut, United States, 06108
Ludlowe Health Care Center
Fairfield, Connecticut, United States, 06825
Glastonbury Health Care Center
Glastonbury, Connecticut, United States, 06033
The Nathaniel Witherell
Greenwich, Connecticut, United States, 06830
Arden House Care and Rehabilitation Center
Hamden, Connecticut, United States, 06514
Hamden Health Care Center
Hamden, Connecticut, United States, 06514
Avery Heights
Hartford, Connecticut, United States, 06106
Wadsworth Glen Health Care and Rehabilitation Center
Middletown, Connecticut, United States, 06457
Water's Edge Center for Health & Rehabilitation
Middletown, Connecticut, United States, 06457
Grimes Center
New Haven, Connecticut, United States, 06511
Mary Wade Home
New Haven, Connecticut, United States, 06511
Advanced Nursing & Rehab Center of New Haven
New Haven, Connecticut, United States, 06519
Shady Knoll Health Center
Seymour, Connecticut, United States, 06483
Lord Chamberlain Nursing & Rehabilitation Center
Stratford, Connecticut, United States, 06614
Village Green of Wallingford
Wallingford, Connecticut, United States, 06492
Abbott Terrace Health Center
Waterbury, Connecticut, United States, 06702
Hughes Health & Rehab Center
West Hartford, Connecticut, United States, 06119
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Manisha Juthani-Mehta, M.D. Yale School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01691430     History of Changes
Other Study ID Numbers: 1112009472
First Posted: September 24, 2012    Key Record Dates
Results First Posted: January 29, 2018
Last Update Posted: January 29, 2018
Last Verified: June 2017

Additional relevant MeSH terms:
Urinary Tract Infections
Bacteriuria
Infection
Urologic Diseases
Proanthocyanidin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents