Trial Outcomes & Findings for A Trial of Cranberry Capsules for Urinary Tract Infection Prevention in Nursing Home Residents (NCT NCT01691430)
NCT ID: NCT01691430
Last Updated: 2020-03-06
Results Overview
Clean catch urine cultures and urinalyses will be obtained every two months for each participant for study purposes.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
185 participants
Primary outcome timeframe
One year
Results posted on
2020-03-06
Participant Flow
Recruited from nursing homes within 50 miles of New Haven.
806 patients were eligible, 558 declined to participate. Of the 248 consented, 63 were found to be ineligible after consent, leaving 185 to randomize.
Participant milestones
| Measure |
2 Cranberry Capsules
Experimental: 2 cranberry capsules
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
2 Placebo Capsules
Experimental: 2 placebo capsules qd
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
93
|
|
Overall Study
Received Medication
|
92
|
93
|
|
Overall Study
COMPLETED
|
70
|
73
|
|
Overall Study
NOT COMPLETED
|
22
|
20
|
Reasons for withdrawal
| Measure |
2 Cranberry Capsules
Experimental: 2 cranberry capsules
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
2 Placebo Capsules
Experimental: 2 placebo capsules qd
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
|---|---|---|
|
Overall Study
Death
|
17
|
16
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
Baseline Characteristics
A Trial of Cranberry Capsules for Urinary Tract Infection Prevention in Nursing Home Residents
Baseline characteristics by cohort
| Measure |
2 Cranberry Capsules
n=92 Participants
Experimental: 2 cranberry capsules
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
2 Placebo Capsules
n=93 Participants
Experimental: 2 placebo capsules qd
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
92 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
185 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
185 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
83 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
167 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Bacteriuria plus pyuria
|
27 participants
n=99 Participants
|
32 participants
n=107 Participants
|
59 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: 147 subjects completed 1 year, 33 died. 20 subjects, 9 in the treatment group v 11 in the control group, became incontinent prior to the first time point, thus unable to provide any urine. 45 subjects stopped taking the capsules, 24 in treatment and 21 in control; 21 refused, 19 transitioned to hospice, 4 started warfarin, and 1 refused via family.
Clean catch urine cultures and urinalyses will be obtained every two months for each participant for study purposes.
Outcome measures
| Measure |
2 Cranberry Capsules
n=92 Participants
Experimental: 2 cranberry capsules
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
2 Placebo Capsules
n=93 Participants
Experimental: 2 placebo capsules qd
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
|---|---|---|
|
Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)
Baseline
|
26 participants
|
32 participants
|
|
Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)
2 months
|
21 participants
|
27 participants
|
|
Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)
4 months
|
15 participants
|
26 participants
|
|
Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)
6 months
|
13 participants
|
20 participants
|
|
Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)
8 months
|
14 participants
|
14 participants
|
|
Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)
10 months
|
15 participants
|
13 participants
|
|
Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)
12 months
|
12 participants
|
9 participants
|
SECONDARY outcome
Timeframe: One yearSuspected 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.
Outcome measures
| Measure |
2 Cranberry Capsules
n=92 Participants
Experimental: 2 cranberry capsules
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
2 Placebo Capsules
n=93 Participants
Experimental: 2 placebo capsules qd
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
|---|---|---|
|
Number of Episodes of Symptomatic UTI
|
10 symptomatic urinary tract infections
|
12 symptomatic urinary tract infections
|
SECONDARY outcome
Timeframe: One yearOutcome measures
| Measure |
2 Cranberry Capsules
n=92 Participants
Experimental: 2 cranberry capsules
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
2 Placebo Capsules
n=93 Participants
Experimental: 2 placebo capsules qd
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
|---|---|---|
|
Number of Hospitalizations
|
33 hospitilizations
|
50 hospitilizations
|
SECONDARY outcome
Timeframe: One yearOutcome measures
| Measure |
2 Cranberry Capsules
n=92 Participants
Experimental: 2 cranberry capsules
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
2 Placebo Capsules
n=93 Participants
Experimental: 2 placebo capsules qd
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
|---|---|---|
|
Number of Deaths
|
17 participants
|
16 participants
|
SECONDARY outcome
Timeframe: One yearChart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant.
Outcome measures
| Measure |
2 Cranberry Capsules
n=92 Participants
Experimental: 2 cranberry capsules
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
2 Placebo Capsules
n=93 Participants
Experimental: 2 placebo capsules qd
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
|---|---|---|
|
Number of Antibiotic Prescriptions
|
1415 prescriptions
|
1883 prescriptions
|
SECONDARY outcome
Timeframe: One yearAll 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).
Outcome measures
| Measure |
2 Cranberry Capsules
n=92 Participants
Experimental: 2 cranberry capsules
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
2 Placebo Capsules
n=93 Participants
Experimental: 2 placebo capsules qd
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
|---|---|---|
|
Bacteriuria With Multidrug-resistant Gram-negative Bacilli
|
9 episodes
|
24 episodes
|
SECONDARY outcome
Timeframe: One YearChart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant's suspected UTI.
Outcome measures
| Measure |
2 Cranberry Capsules
n=92 Participants
Experimental: 2 cranberry capsules
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
2 Placebo Capsules
n=93 Participants
Experimental: 2 placebo capsules qd
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
|---|---|---|
|
Number of Antibiotic Prescriptions for Suspected UTI
|
692 prescriptions
|
909 prescriptions
|
SECONDARY outcome
Timeframe: One yearPopulation: There were 10 symptomatic UTIs in the treatment group (8 participants with 1 episode and 1 participant with 2 episodes) and 12 symptomatic UTIs in the control group (7 participants with 1 episode, 1 participant with 2 episodes, and 1 participant with 3 episodes).
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.
Outcome measures
| Measure |
2 Cranberry Capsules
n=92 Participants
Experimental: 2 cranberry capsules
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
2 Placebo Capsules
n=93 Participants
Experimental: 2 placebo capsules qd
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
|---|---|---|
|
Subjects With 1, 2, or 3 Episodes of UTIs
1 episode
|
8 participants
|
7 participants
|
|
Subjects With 1, 2, or 3 Episodes of UTIs
2 episodes
|
1 participants
|
1 participants
|
|
Subjects With 1, 2, or 3 Episodes of UTIs
3 episodes
|
0 participants
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One yearOutcome measures
| Measure |
2 Cranberry Capsules
n=92 Participants
Experimental: 2 cranberry capsules
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
2 Placebo Capsules
n=93 Participants
Experimental: 2 placebo capsules qd
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
|---|---|---|
|
Number of Adverse Events in Participants
Serious unrelated
|
50 adverse events
|
66 adverse events
|
|
Number of Adverse Events in Participants
non-serious unrelated
|
1731 adverse events
|
1966 adverse events
|
|
Number of Adverse Events in Participants
non-serious related
|
7 adverse events
|
7 adverse events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One yearmeasured by capsules removed from blister packs
Outcome measures
| Measure |
2 Cranberry Capsules
n=92 Participants
Experimental: 2 cranberry capsules
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
2 Placebo Capsules
n=93 Participants
Experimental: 2 placebo capsules qd
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
|---|---|---|
|
Adherence to Capsule Intake by All Participants
|
77.5 percentage of capsules
|
82.6 percentage of capsules
|
Adverse Events
2 Cranberry Capsules
Serious events: 50 serious events
Other events: 92 other events
Deaths: 0 deaths
2 Placebo Capsules
Serious events: 66 serious events
Other events: 93 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2 Cranberry Capsules
n=92 participants at risk
Experimental: 2 cranberry capsules
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
2 Placebo Capsules
n=93 participants at risk
Experimental: 2 placebo capsules qd
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
|---|---|---|
|
General disorders
Hospitalization
|
35.9%
33/92
|
53.8%
50/93
|
|
General disorders
Death
|
18.5%
17/92 • Number of events 17
|
17.2%
16/93 • Number of events 16
|
Other adverse events
| Measure |
2 Cranberry Capsules
n=92 participants at risk
Experimental: 2 cranberry capsules
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
2 Placebo Capsules
n=93 participants at risk
Experimental: 2 placebo capsules qd
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
|
|---|---|---|
|
Blood and lymphatic system disorders
Abnormal blood glucose
|
9.8%
9/92
|
11.8%
11/93
|
|
Respiratory, thoracic and mediastinal disorders
Acute chest pain
|
9.8%
9/92
|
11.8%
11/93
|
|
Renal and urinary disorders
Acute renal failure
|
1.1%
1/92
|
0.00%
0/93
|
|
Psychiatric disorders
Altered mental status
|
57.6%
53/92
|
65.6%
61/93
|
|
Blood and lymphatic system disorders
Anemia
|
4.3%
4/92
|
4.3%
4/93
|
|
General disorders
Back Pain
|
12.0%
11/92
|
18.3%
17/93
|
|
Blood and lymphatic system disorders
Blood pressure alteration
|
15.2%
14/92
|
15.1%
14/93
|
|
Gastrointestinal disorders
constipation
|
51.1%
47/92
|
54.8%
51/93
|
|
General disorders
dehydration
|
1.1%
1/92
|
1.1%
1/93
|
|
Nervous system disorders
dizziness
|
4.3%
4/92
|
6.5%
6/93
|
|
Ear and labyrinth disorders
ear problem
|
6.5%
6/92
|
11.8%
11/93
|
|
General disorders
edema
|
18.5%
17/92
|
22.6%
21/93
|
|
Infections and infestations
exposure to influenza
|
10.9%
10/92
|
14.0%
13/93
|
|
Eye disorders
eye infection
|
19.6%
18/92
|
18.3%
17/93
|
|
General disorders
Fall
|
52.2%
48/92
|
59.1%
55/93
|
|
General disorders
fever
|
19.6%
18/92
|
22.6%
21/93
|
|
Gastrointestinal disorders
GI disturbance
|
57.6%
53/92
|
57.0%
53/93
|
|
General disorders
Generalized malaise
|
31.5%
29/92
|
29.0%
27/93
|
|
General disorders
headache
|
10.9%
10/92
|
20.4%
19/93
|
|
General disorders
insomnia
|
6.5%
6/92
|
10.8%
10/93
|
|
General disorders
joint pain
|
39.1%
36/92
|
33.3%
31/93
|
|
General disorders
lab abnormality
|
45.7%
42/92
|
46.2%
43/93
|
|
Musculoskeletal and connective tissue disorders
leg pain
|
8.7%
8/92
|
9.7%
9/93
|
|
General disorders
oral cavity disturbance
|
37.0%
34/92
|
26.9%
25/93
|
|
Respiratory, thoracic and mediastinal disorders
respiratory difficulty
|
59.8%
55/92
|
63.4%
59/93
|
|
Skin and subcutaneous tissue disorders
skin/soft tissue event
|
77.2%
71/92
|
89.2%
83/93
|
|
Renal and urinary disorders
Urinary Tract Infection
|
35.9%
33/92
|
47.3%
44/93
|
|
Metabolism and nutrition disorders
weight gain
|
45.7%
42/92
|
51.6%
48/93
|
|
Metabolism and nutrition disorders
weight loss
|
67.4%
62/92
|
79.6%
74/93
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place