A Trial of Cranberry Capsules for Urinary Tract Infection Prevention in Nursing Home Residents
A Randomized, Controlled Trial of Cranberry Capsules for UTI Prevention in Nursing Home Residents
3 other identifiers
interventional
185
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2012
Typical duration for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 9, 2012
CompletedFirst Posted
Study publicly available on registry
September 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
January 29, 2018
CompletedMarch 6, 2020
March 1, 2020
3.2 years
August 9, 2012
February 14, 2017
March 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)
Clean catch urine cultures and urinalyses will be obtained every two months for each participant for study purposes.
One year
Secondary Outcomes (7)
Number of Episodes of Symptomatic UTI
One year
Number of Hospitalizations
One year
Number of Deaths
One year
Number of Antibiotic Prescriptions
One year
Bacteriuria With Multidrug-resistant Gram-negative Bacilli
One year
- +2 more secondary outcomes
Other Outcomes (2)
Number of Adverse Events in Participants
One year
Adherence to Capsule Intake by All Participants
One year
Study Arms (2)
2 cranberry capsules
ACTIVE COMPARATORExperimental: 2 cranberry capsules
2 placebo capsules
PLACEBO COMPARATORExperimental: 2 placebo capsules qd
Interventions
Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
Eligibility Criteria
You may qualify if:
- female residents;
- long term residents
- English speaking; and
- age ≥ 65 years.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute on Aging (NIA)collaborator
Study Sites (21)
Branford Hills Health Care
Branford, Connecticut, 06405, United States
Northbridge Health Care Center
Bridgeport, Connecticut, 06606, United States
Bridgeport Health Care Center
Bridgeport, Connecticut, 06610, United States
Bridgeport Manor
Bridgeport, Connecticut, 06610, United States
Riverside Health & Rehabilitation Center
East Hartford, Connecticut, 06108, United States
Ludlowe Health Care Center
Fairfield, Connecticut, 06825, United States
Glastonbury Health Care Center
Glastonbury, Connecticut, 06033, United States
The Nathaniel Witherell
Greenwich, Connecticut, 06830, United States
Arden House Care and Rehabilitation Center
Hamden, Connecticut, 06514, United States
Hamden Health Care Center
Hamden, Connecticut, 06514, United States
Avery Heights
Hartford, Connecticut, 06106, United States
Wadsworth Glen Health Care and Rehabilitation Center
Middletown, Connecticut, 06457, United States
Water's Edge Center for Health & Rehabilitation
Middletown, Connecticut, 06457, United States
Grimes Center
New Haven, Connecticut, 06511, United States
Mary Wade Home
New Haven, Connecticut, 06511, United States
Advanced Nursing & Rehab Center of New Haven
New Haven, Connecticut, 06519, United States
Shady Knoll Health Center
Seymour, Connecticut, 06483, United States
Lord Chamberlain Nursing & Rehabilitation Center
Stratford, Connecticut, 06614, United States
Village Green of Wallingford
Wallingford, Connecticut, 06492, United States
Abbott Terrace Health Center
Waterbury, Connecticut, 06702, United States
Hughes Health & Rehab Center
West Hartford, Connecticut, 06119, United States
Related Publications (4)
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.
PMID: 37947276DERIVEDWilliams 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.
PMID: 37068952DERIVEDDatta R, Trentalange M, Van Ness PH, McGloin JM, Guralnik JM, Miller ME, Walkup MP, Nadkarni N, Pahor M, Gill TM, Quagliarello V, Juthani-Mehta M; LIFE Study Group. Serious adverse events of older adults in nursing home and community intervention trials. Contemp Clin Trials Commun. 2017 Dec 21;9:77-80. doi: 10.1016/j.conctc.2017.12.004. eCollection 2018 Mar.
PMID: 29696228DERIVEDJuthani-Mehta M, Van Ness PH, Bianco L, Rink A, Rubeck S, Ginter S, Argraves S, Charpentier P, Acampora D, Trentalange M, Quagliarello V, Peduzzi P. Effect of Cranberry Capsules on Bacteriuria Plus Pyuria Among Older Women in Nursing Homes: A Randomized Clinical Trial. JAMA. 2016 Nov 8;316(18):1879-1887. doi: 10.1001/jama.2016.16141.
PMID: 27787564DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Manisha Juthani-Mehta
- Organization
- Yale University
Study Officials
- PRINCIPAL INVESTIGATOR
Manisha Juthani-Mehta, M.D.
Yale University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2012
First Posted
September 24, 2012
Study Start
August 1, 2012
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
March 6, 2020
Results First Posted
January 29, 2018
Record last verified: 2020-03