JAMA. 2016 Oct 27. doi: 10.1001/jama.2016.16141. [Epub ahead of print]
Juthani-Mehta M1,
Van Ness PH2,
Bianco L2,
Rink A2,
Rubeck S2,
Ginter S2,
Argraves S2,
Charpentier P2,
Acampora D2,
Trentalange M2,
Quagliarello V1,
Peduzzi P3.
- 1Section of Infectious Diseases, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
- 2Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
- 3Yale Center for Analytical Sciences, Department of Biostatistics, Yale School of Public Health, New Haven, Connecticut.
Abstract
Importance:
Bacteriuria plus pyuria is highly prevalent among older women living in nursing homes. Cranberry capsules are an understudied, nonantimicrobial prevention strategy used in this population.
Objective:
To test the effect of 2 oral cranberry capsules once a day on presence of bacteriuria plus pyuria among women residing in nursing homes.
Design, Setting, and Participants:
Double-blind,
randomized, placebo-controlled efficacy trial with stratification by
nursing home and involving 185 English-speaking women aged 65 years or
older, with or without bacteriuria plus pyuria at baseline, residing in
21 nursing homes located within 50 miles (80 km) of New Haven,
Connecticut (August 24, 2012-October 26, 2015).
Interventions:
Two oral cranberry capsules, each capsule containing 36 mg of the active ingredient proanthocyanidin (ie, 72 mg total, equivalent to 20 ounces of cranberry juice) vs placebo administered once a day in 92 treatment and 93 control group participants.
Main Outcomes and Measures:
Presence
of bacteriuria (ie, at least 105 colony-forming units [CFUs] per
milliliter of 1 or 2 microorganisms in urine culture) plus pyuria (ie,
any number of white blood cells on urinalysis) assessed every 2 months
over the 1-year study surveillance; any positive finding was considered
to meet the primary outcome. Secondary outcomes were symptomatic urinary tract infection
(UTI), all-cause death, all-cause hospitalization, all multidrug
antibiotic-resistant organisms, antibiotics administered for suspected
UTI, and total antimicrobial administration.
Results:
Of
the 185 randomized study participants (mean age, 86.4 years [SD, 8.2],
90.3% white, 31.4% with bacteriuria plus pyuria at baseline), 147
completed the study. Overall adherence was 80.1%. Unadjusted results
showed the presence of bacteriuria plus pyuria in 25.5% (95% CI,
18.6%-33.9%) of the treatment group and in 29.5% (95% CI, 22.2%-37.9%)
of the control group. The adjusted generalized estimating equations
model that accounted for missing data and covariates showed no
significant difference in the presence of bacteriuria plus pyuria
between the treatment group vs the control group (29.1% vs 29.0%; OR,
1.01; 95% CI, 0.61-1.66; P = .98). There were no significant differences
in number of symptomatic UTIs (10 episodes in the treatment group vs 12
in the control group), rates of death (17 vs 16 deaths; 20.4 vs 19.1
deaths/100 person-years; rate ratio [RR], 1.07; 95% CI, 0.54-2.12),
hospitalization (33 vs 50 admissions; 39.7 vs 59.6 hospitalizations/100
person-years; RR, 0.67; 95% CI, 0.32-1.40), bacteriuria associated with
multidrug-resistant gram-negative bacilli (9 vs 24 episodes; 10.8 vs
28.6 episodes/100 person-years; RR, 0.38; 95% CI, 0.10-1.46),
antibiotics administered for suspected UTIs (692 vs 909 antibiotic days;
8.3 vs 10.8 antibiotic days/person-year; RR, 0.77; 95% CI, 0.44-1.33),
or total antimicrobial utilization (1415 vs 1883 antimicrobial days;
17.0 vs 22.4 antimicrobial days/person-year; RR, 0.76; 95% CI,
0.46-1.25).
Conclusions and Relevance:
Among older women residing in nursing homes, administration of cranberry capsules vs placebo resulted in no significant difference in presence of bacteriuria plus pyuria over 1 year.
Trial Registration:
clinicaltrials.gov Identifier:
NCT01691430.
