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

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.

Study Overview

• Status: Completed
• Conditions: Bacteriuria
• Intervention / Treatment: Dietary supplement: 2 cranberry capsules; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Branford, Connecticut, United States, 06405
      • Branford Hills Health Care
    • Bridgeport, Connecticut, United States, 06606
      • Northbridge Health Care Center
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Health Care Center
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Manor
    • East Hartford, Connecticut, United States, 06108
      • Riverside Health & Rehabilitation Center
    • Fairfield, Connecticut, United States, 06825
      • Ludlowe Health Care Center
    • Glastonbury, Connecticut, United States, 06033
      • Glastonbury Health Care Center
    • Greenwich, Connecticut, United States, 06830
      • The Nathaniel Witherell
    • Hamden, Connecticut, United States, 06514
      • Arden House Care and Rehabilitation Center
    • Hamden, Connecticut, United States, 06514
      • Hamden Health Care Center
    • Hartford, Connecticut, United States, 06106
      • Avery Heights
    • Middletown, Connecticut, United States, 06457
      • Wadsworth Glen Health Care and Rehabilitation Center
    • Middletown, Connecticut, United States, 06457
      • Water's Edge Center for Health & Rehabilitation
    • New Haven, Connecticut, United States, 06511
      • Grimes Center
    • New Haven, Connecticut, United States, 06511
      • Mary Wade Home
    • New Haven, Connecticut, United States, 06519
      • Advanced Nursing & Rehab Center of New Haven
    • Seymour, Connecticut, United States, 06483
      • Shady Knoll Health Center
    • Stratford, Connecticut, United States, 06614
      • Lord Chamberlain Nursing & Rehabilitation Center
    • Wallingford, Connecticut, United States, 06492
      • Village Green of Wallingford
    • Waterbury, Connecticut, United States, 06702
      • Abbott Terrace Health Center
    • West Hartford, Connecticut, United States, 06119
      • Hughes Health & Rehab Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2 cranberry capsules; Experimental: 2 cranberry capsules	Dietary supplement: 2 cranberry capsules; Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
Placebo Comparator: 2 placebo capsules; Experimental: 2 placebo capsules qd	Dietary supplement: Placebo; Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of Hospitalizations		One year
Number of Deaths		One year
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events in Participants		One year
Adherence to Capsule Intake by All Participants	measured by capsules removed from blister packs	One year

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Manisha Juthani-Mehta, M.D., Yale School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: August 9, 2012
• First Submitted That Met QC Criteria: September 19, 2012
• First Posted (Estimate): September 24, 2012

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections; Bacteriuria
• Other Study ID Numbers: 1112009472; 2P30AG021342-11 (U.S. NIH Grant/Contract); 1R01AG041153-01A1 (U.S. NIH Grant/Contract)