Clinical trial NCT01691430: A Trial of Cranberry Capsules for Urinary Tract Infection Prevention in Nursing Home Residents
Official title: A Randomized, Controlled Trial of Cranberry Capsules for UTI Prevention in Nursing Home Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacteriuria
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2012-09-24
Enrollment: 185
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomized to cranberry or placebo capsules.
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)
timeFrame: One year
Secondary outcomes:
measure: Number of Episodes of Symptomatic UTI
timeFrame: One year
measure: Number of Hospitalizations
timeFrame: One year
measure: Number of Deaths
timeFrame: One year
measure: Number of Antibiotic Prescriptions
timeFrame: One year
measure: Bacteriuria With Multidrug-resistant Gram-negative Bacilli
timeFrame: One year
measure: Number of Antibiotic Prescriptions for Suspected UTI
timeFrame: One Year
measure: Subjects With 1, 2, or 3 Episodes of UTIs
timeFrame: One year
Other outcomes:
measure: Number of Adverse Events in Participants
timeFrame: One year
measure: Adherence to Capsule Intake by All Participants
timeFrame: One year
Locations:
city: Branford
country: United States
facility: Branford Hills Health Care
state: Connecticut
city: Bridgeport
country: United States
facility: Northbridge Health Care Center
state: Connecticut
city: Bridgeport
country: United States
facility: Bridgeport Health Care Center
state: Connecticut
city: Bridgeport
country: United States
facility: Bridgeport Manor
state: Connecticut
city: East Hartford
country: United States
facility: Riverside Health & Rehabilitation Center
state: Connecticut
city: Fairfield
country: United States
facility: Ludlowe Health Care Center
state: Connecticut
city: Glastonbury
country: United States
facility: Glastonbury Health Care Center
state: Connecticut
city: Greenwich
country: United States
facility: The Nathaniel Witherell
state: Connecticut
city: Hamden
country: United States
facility: Arden House Care and Rehabilitation Center
state: Connecticut
city: Hamden
country: United States
facility: Hamden Health Care Center
state: Connecticut
city: Hartford
country: United States
facility: Avery Heights
state: Connecticut
city: Middletown
country: United States
facility: Wadsworth Glen Health Care and Rehabilitation Center
state: Connecticut
city: Middletown
country: United States
facility: Water's Edge Center for Health & Rehabilitation
state: Connecticut
city: New Haven
country: United States
facility: Grimes Center
state: Connecticut
city: New Haven
country: United States
facility: Mary Wade Home
state: Connecticut
city: New Haven
country: United States
facility: Advanced Nursing & Rehab Center of New Haven
state: Connecticut
city: Seymour
country: United States
facility: Shady Knoll Health Center
state: Connecticut
city: Stratford
country: United States
facility: Lord Chamberlain Nursing & Rehabilitation Center
state: Connecticut
city: Wallingford
country: United States
facility: Village Green of Wallingford
state: Connecticut
city: Waterbury
country: United States
facility: Abbott Terrace Health Center
state: Connecticut
city: West Hartford
country: United States
facility: Hughes Health & Rehab Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Manisha Juthani-Mehta, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Datta 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.
citation: Juthani-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.