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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01691430
First received: August 9, 2012
Last updated: January 21, 2015
Last verified: January 2015
  Purpose

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 prevention of bacteriuria in female nursing home residents. The secondary aim is to compare the occurrence of urinary tract specific symptoms in the cranberry capsule versus placebo groups. 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 Intervention Phase
Bacteriuria
Dietary Supplement: 2 cranberry capsules
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Controlled Trial of Cranberry Capsules for UTI Prevention in Nursing Home Residents

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Number of urine cultures with bacteriuria (>100,000 cfu/ml) plus pyuria (>10 WBC) [ Time Frame: One year ] [ Designated as safety issue: No ]
    Clean catch urine cultures and urinalyses will be obtained every two months for each participant for study purposes.


Secondary Outcome Measures:
  • Number of episodes of UTI [ Time Frame: One year ] [ Designated as safety issue: No ]
    UTI episodes that are recorded in the medical record by the primary provider will be collected by chart review.

  • Number of hospitalizations [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Number of deaths [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Number of antibiotic prescriptions [ Time Frame: One year ] [ Designated as safety issue: No ]
    Chart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant.

  • Number of multi-drug resistant organisms in each participant [ Time Frame: One year ] [ Designated as safety issue: No ]
    Chart review will be performed to determine if multi-drug resistant organisms were isolated from clinical samples (e.g., sputum, urine, blood cultures) submitted by the primary provider.


Other Outcome Measures:
  • Number of adverse events in participants [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Adherence to capsule intake by all participants [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: August 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2 cranberry capsules
Experimental: 2 cranberry capsules
Dietary Supplement: 2 cranberry capsules
Two 36mg cranberry capsules all qhs
Other Name: Ellura
Placebo Comparator: 2 placebo capsules
Experimental: 2 placebo capsules all qhs
Dietary Supplement: Placebo
Two 36mg placebo capsules all qhs
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. female residents;
  2. age ≥ 65 years;
  3. long term residents

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691430

Locations
United States, Connecticut
Branford Hills Health Care
Branford, Connecticut, United States, 06405
Bridgeport Health Care Center
Bridgeport, Connecticut, United States, 06610
Bridgeport Manor
Bridgeport, Connecticut, United States, 06610
Northbridge Health Care Center
Bridgeport, Connecticut, United States, 06606
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
Advanced Nursing & Rehab Center of New Haven
New Haven, Connecticut, United States, 06519
Grimes Center
New Haven, Connecticut, United States, 06511
Mary Wade Home
New Haven, Connecticut, United States, 06511
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
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01691430     History of Changes
Other Study ID Numbers: 1112009472
Study First Received: August 9, 2012
Last Updated: January 21, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on March 26, 2015