CompletedNCT01691430Updated Mar 6, 2020Results posted

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

A Phase 3 interventional study of 2 cranberry capsules and Placebo in Bacteriuria, sponsored by Yale University. Completed at 21 sites in United States. Open to female participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-06.

Sponsored by Yale University · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 185
Allocation: Randomized
Ages: 65 Years and older
Sex: Female

Study 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.

Conditions studied

Bacteriuria

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Bacteriuria 51

In context

Bacteriuria

51 studies on the registry are indexed under Bacteriuria; 3 are open to participants now.

This study's enrollment of 185 is above the median of 100 across 37 interventional studies indexed under Bacteriuria.

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Lead sponsor

Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.

Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 65 Years and older
Sexes eligible: Female
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

female residents;
long term residents
English speaking; and
age ≥ 65 years.

Exclusion criteria

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 [ \< 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy: The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 185 participants (actual)

Study arms

Active comparator
2 cranberry capsules
Experimental: 2 cranberry capsules
Dietary Supplement: 2 cranberry capsules
Placebo comparator
2 placebo capsules
Experimental: 2 placebo capsules qd
Dietary Supplement: Placebo

Interventions

Dietary supplement2 cranberry capsules
Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
Dietary supplementPlacebo
Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)

What researchers measure

Primary outcomes

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.
Time frame: One year

Secondary outcomes

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.
Time frame: One year
Number of Hospitalizations
Time frame: One year
Number of Deaths
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: One year

Other outcomes

Number of Adverse Events in Participants
Time frame: One year
Adherence to Capsule Intake by All Participants
measured by capsules removed from blister packs
Time frame: One year

Results

Posted Jan 29, 2018

Participant flow

Recruited from nursing homes within 50 miles of New Haven.

Participant flow — Overall Study
Milestone	2 Cranberry Capsules	2 Placebo Capsules
Started	92	93
Received medication	92	93
Completed	70	73
Not completed	22	20
Withdrew: Death	17	16
Withdrew: Withdrawal by subject	5	1
Withdrew: Lost to follow-up	0	3

Outcome measures

PrimaryParticipants 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.

Time frame:: One year
Reported as:: Number · participants

Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)
participants	2 Cranberry Capsules	2 Placebo Capsules
Baseline	26	32
2 months	21	27
4 months	15	26
6 months	13	20
8 months	14	14
10 months	15	13
12 months	12	9

SecondaryNumber 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.

Time frame:: One year
Reported as:: Number · symptomatic urinary tract infections

Number of Episodes of Symptomatic UTI
symptomatic urinary tract infections	2 Cranberry Capsules	2 Placebo Capsules
Number of Episodes of Symptomatic UTI	10	12

SecondaryNumber of Hospitalizations

Time frame:: One year
Reported as:: Number · hospitilizations

Number of Hospitalizations
hospitilizations	2 Cranberry Capsules	2 Placebo Capsules
Number of Hospitalizations	33	50

SecondaryNumber of Deaths

Time frame:: One year
Reported as:: Number · participants

Number of Deaths
participants	2 Cranberry Capsules	2 Placebo Capsules
Number of Deaths	17	16

SecondaryNumber 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.

Time frame:: One year
Reported as:: Number · prescriptions

Number of Antibiotic Prescriptions
prescriptions	2 Cranberry Capsules	2 Placebo Capsules
Number of Antibiotic Prescriptions	1415	1883

SecondaryBacteriuria 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).

Time frame:: One year
Reported as:: Number · episodes

Bacteriuria With Multidrug-resistant Gram-negative Bacilli
episodes	2 Cranberry Capsules	2 Placebo Capsules
Bacteriuria With Multidrug-resistant Gram-negative Bacilli	9	24

SecondaryNumber 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.

Time frame:: One Year
Reported as:: Number · prescriptions

Number of Antibiotic Prescriptions for Suspected UTI
prescriptions	2 Cranberry Capsules	2 Placebo Capsules
Number of Antibiotic Prescriptions for Suspected UTI	692	909

Other pre-specifiedNumber of Adverse Events in Participants

Time frame:: One year
Reported as:: Number · adverse events

Number of Adverse Events in Participants
adverse events	2 Cranberry Capsules	2 Placebo Capsules
Serious unrelated	50	66
non-serious unrelated	1731	1966
non-serious related	7	7

Other pre-specifiedAdherence to Capsule Intake by All Participants

measured by capsules removed from blister packs

Time frame:: One year
Reported as:: Number · percentage of capsules

Adherence to Capsule Intake by All Participants
percentage of capsules	2 Cranberry Capsules	2 Placebo Capsules
Adherence to Capsule Intake by All Participants	77.5	82.6

SecondarySubjects With 1, 2, or 3 Episodes of UTIs

Time frame:: One year
Reported as:: Number · participants

Subjects With 1, 2, or 3 Episodes of UTIs
participants	2 Cranberry Capsules	2 Placebo Capsules
1 episode	8	7
2 episodes	1	1
3 episodes	0	1

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
2 Cranberry Capsules	—	50/92 (54.3%)	92/92 (100%)
2 Placebo Capsules	—	66/93 (71%)	93/93 (100%)

Most frequent serious events

Most frequent serious events
Event	2 Cranberry Capsules	2 Placebo Capsules
HospitalizationGeneral disorders	33/92	50/93
DeathGeneral disorders	17/92	16/93

Most frequent other events

Showing 10 of 29

Most frequent other events
Event	2 Cranberry Capsules	2 Placebo Capsules
skin/soft tissue eventSkin and subcutaneous tissue disorders	71/92	83/93
weight lossMetabolism and nutrition disorders	62/92	74/93
Altered mental statusPsychiatric disorders	53/92	61/93
respiratory difficultyRespiratory, thoracic and mediastinal disorders	55/92	59/93
FallGeneral disorders	48/92	55/93
GI disturbanceGastrointestinal disorders	53/92	53/93
constipationGastrointestinal disorders	47/92	51/93
weight gainMetabolism and nutrition disorders	42/92	48/93
Urinary Tract InfectionRenal and urinary disorders	33/92	44/93
lab abnormalityGeneral disorders	42/92	43/93

Baseline characteristics

Inclusion criteria were (1) female; (2) long-term care residents; (3) English speaking; and (4) 65 years or older.

Age, Categorical
Age, Categorical(Participants)	2 Cranberry Capsules	2 Placebo Capsules	Total
<=18 years	0	0	0
Between 18 and 65 years	0	0	0
>=65 years	92	93	185

Sex: Female, Male
Sex: Female, Male(Participants)	2 Cranberry Capsules	2 Placebo Capsules	Total
Female	92	93	185
Male	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	2 Cranberry Capsules	2 Placebo Capsules	Total
White	83	84	167
Non-White	9	9	18

Bacteriuria plus pyuria
Bacteriuria plus pyuria(participants)	2 Cranberry Capsules	2 Placebo Capsules	Total
Number	27	32	59

Study locations

21 sites

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

References and documents

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. PubMed 29696228 ↗
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. PubMed 27787564 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2012, a primary completion of Oct 2015 and a completion of Oct 2015. It does not say whether these dates are actual or estimated.

Results were first posted in Jan 2018, 2 years 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 9, 2012
First posted: Sep 24, 2012
Start: Aug 2012
Primary completionActual: Oct 2015
CompletionActual: Oct 2015
Results first posted: Jan 29, 2018
Last update: Mar 6, 2020

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01691430
Lead sponsor: Yale University
Collaborators: National Institute on Aging (NIA)
Responsible party: Sponsor
First posted: Sep 24, 2012
Start date: Aug 2012
Primary completion: Oct 2015
Completion: Oct 2015
Results posted: Jan 29, 2018
Last update: Mar 6, 2020

Study contacts

Manisha Juthani-Mehta, M.D.

principal investigator · Yale School of Medicine

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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