A Trial of Cranberry Capsules for Urinary Tract Infection Prevention in Nursing Home Residents
This study is currently recruiting participants.
Verified May 2013 by Yale University
Sponsor:
Yale University
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01691430
First received: August 9, 2012
Last updated: May 13, 2013
Last verified: May 2013
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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: | 180 |
| 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:
- female residents;
- age ≥ 65 years;
- long term residents
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691430
Contacts
| Contact: Manisha Juthani-Mehta, M.D. | 203-737-2109 | manisha.juthanimehta@yale.edu |
Locations
| United States, Connecticut | |
| Caleb Hitchcock Health Center at Duncaster | Not yet recruiting |
| Bloomfield, Connecticut, United States, 06002 | |
| Contact: Carol Mortensen, RN 860-726-2400 | |
| Northbridge Health Care Center | Recruiting |
| Bridgeport, Connecticut, United States, 06606 | |
| Contact: Helen Byron 203-336-0232 | |
| Countryside Manor of Bristol | Not yet recruiting |
| Bristol, Connecticut, United States, 06010 | |
| Contact: Charles Hallgren 860-583-8483 | |
| Cherry Brook Health Care Center | Not yet recruiting |
| Canton, Connecticut, United States, 06019 | |
| Contact: Susan Vinal 860-693-7777 | |
| Ludlowe Health Care Center | Not yet recruiting |
| Fairfield, Connecticut, United States, 06825 | |
| Contact: Lew Abramson 203-372-4501 | |
| Glastonbury Health Care Center | Recruiting |
| Glastonbury, Connecticut, United States, 06033 | |
| Contact: Elizabeth Schmeizl 860-659-1905 | |
| Meadowbrook of Granby | Not yet recruiting |
| Granby, Connecticut, United States, 06035 | |
| Contact: Don Davanzo 860-653-9888 | |
| Arden House Care and Rehabilitation Center | Recruiting |
| Hamden, Connecticut, United States, 06514 | |
| Contact: Kevin Cleary 203-281-3500 | |
| Hamden Health Care Center | Not yet recruiting |
| Hamden, Connecticut, United States, 06514 | |
| Contact: Linda Odaynik 203-281-7555 | |
| Wadsworth Glen Health Care and Rehabilitation Center | Recruiting |
| Middletown, Connecticut, United States, 06457 | |
| Contact: William Nelson 860-346-9299 | |
| Middlesex Health Care Center | Not yet recruiting |
| Middletown, Connecticut, United States, 06457 | |
| Contact: David Sones 860-344-0353 | |
| Shady Knoll Health Center | Recruiting |
| Seymour, Connecticut, United States, 06483 | |
| Contact: Deborah Torrey 203-881-2555 | |
| The Smith House Health Care Center | Not yet recruiting |
| Stamford, Connecticut, United States, 06903 | |
| Contact: Jamie Aurand 203-322-3428 | |
| Lord Chamberlain Nursing & Rehabilitation Center | Recruiting |
| Stratford, Connecticut, United States, 06614 | |
| Contact: James Bergers 203-375-5894 | |
| Valerie Manor | Not yet recruiting |
| Torrington, Connecticut, United States, 06790 | |
| Contact: Thomas Walkuski 860-489-1008 | |
| Litchfield Woods Health Care Center | Not yet recruiting |
| Torrington, Connecticut, United States, 06790 | |
| Contact: Denise Quarles 860-489-5801 | |
| Maefair Health Care Center | Not yet recruiting |
| Trumbull, Connecticut, United States, 06611 | |
| Contact: Daniel Brencher 203-459-5152 | |
| Village Green of Wallingford | Not yet recruiting |
| Wallingford, Connecticut, United States, 06492 | |
| Contact: Kimberly Coleman 203-265-6771 | |
| Abbott Terrace Health Center | Recruiting |
| Waterbury, Connecticut, United States, 06702 | |
| Contact: Richard Slutsky 203-755-4870 | |
| Saint Mary Home | Not yet recruiting |
| West Hartford, Connecticut, United States, 06117 | |
| Contact: Patricia Hamill 860-570-8200 | |
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: | May 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Bacteriuria Urinary Tract Infections Infection Urologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013