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

Bacteriuria Clinical Trial

Official title:

A Randomized, Controlled Trial of Cranberry Capsules for UTI Prevention in Nursing Home Residents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691430
• Other study ID #: 1112009472
• Secondary ID: 2P30AG021342-111
• Status: Completed
• Phase: Phase 3
• Start date: August 2012
• Est. completion date: October 2015

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacteriuria

Intervention

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

Locations

Country	Name	City	State
United States	Branford Hills Health Care	Branford	Connecticut
United States	Bridgeport Health Care Center	Bridgeport	Connecticut
United States	Bridgeport Manor	Bridgeport	Connecticut
United States	Northbridge Health Care Center	Bridgeport	Connecticut
United States	Riverside Health & Rehabilitation Center	East Hartford	Connecticut
United States	Ludlowe Health Care Center	Fairfield	Connecticut
United States	Glastonbury Health Care Center	Glastonbury	Connecticut
United States	The Nathaniel Witherell	Greenwich	Connecticut
United States	Arden House Care and Rehabilitation Center	Hamden	Connecticut
United States	Hamden Health Care Center	Hamden	Connecticut
United States	Avery Heights	Hartford	Connecticut
United States	Wadsworth Glen Health Care and Rehabilitation Center	Middletown	Connecticut
United States	Water's Edge Center for Health & Rehabilitation	Middletown	Connecticut
United States	Advanced Nursing & Rehab Center of New Haven	New Haven	Connecticut
United States	Grimes Center	New Haven	Connecticut
United States	Mary Wade Home	New Haven	Connecticut
United States	Shady Knoll Health Center	Seymour	Connecticut
United States	Lord Chamberlain Nursing & Rehabilitation Center	Stratford	Connecticut
United States	Village Green of Wallingford	Wallingford	Connecticut
United States	Abbott Terrace Health Center	Waterbury	Connecticut
United States	Hughes Health & Rehab Center	West Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Adverse Events in Participants		One year
Other	Adherence to Capsule Intake by All Participants	measured by capsules removed from blister packs	One year
Primary	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	Number of Episodes of Symptomatic UTI	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.	One year
Secondary	Number of Hospitalizations		One year
Secondary	Number of Deaths		One year
Secondary	Number of Antibiotic Prescriptions	Chart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant.	One year
Secondary	Bacteriuria With Multidrug-resistant Gram-negative Bacilli	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).	One year
Secondary	Number of Antibiotic Prescriptions for Suspected UTI	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.	One Year
Secondary	Subjects With 1, 2, or 3 Episodes of UTIs	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.	One year