Methods |
Study design: parallel, open‐label RCT
Duration of study:1992 to 1993
Duration of follow‐up: 6 months
|
Participants |
Country: Greece
Setting: aged care facility
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Inclusion criteria: men and women ≥ 65 years; freely voiding; asymptomatic; strain susceptible to ofloxacin
Number: treatment group 1 (34); treatment group 2 (33); control group (29)
Mean age, 95% CI (years): treatment group 1 (84.5, 72.2 to 96.8); treatment group 2 (82.8, 72.6 to 90.2); control group (82.9, 70.8 to 91.8)
Sex (M/F): treatment group 1 (6/28); treatment group 2 (2/31); control group (7/22)
Exclusion criteria: major musculoskeletal problems; incontinence; bladder catheter; recent manipulations of urinary tract; creatinine > 2 mg%; antibiotics within the previous 3 months; subjects needing help for basic daily living activities
|
Interventions |
Treatment group 1
Treatment group 2
Control group
|
Outcomes |
Overall mortality
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Bacteriological cure at 3 and 6 months
Adverse events
Development of resistance
Physical impairment
Kidney and hepatic status
|
Notes |
Most E. coli in all groups
106 enrolled,16 men, 90 women, 10 did not accept programme, 96 randomised
Follow‐up at 6 months: urinalysis and urine culture before treatment and once monthly for 6 months
Fourth group of randomly selected, age‐matched individuals with repeatedly negative monthly cultures in the last year of the study was included as negative controls (40 people)
Grants from Hoechst‐Roussell Hellas and the Sandoz Foundation for Gerontological Research
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Randomised, not described |
Allocation concealment (selection bias) |
Unclear risk |
Not reported |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Open‐label study |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Open‐label study |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Loss to follow‐up described; treatment groups (refused (3), adverse events (2)); control group (refused (1)) |
Selective reporting (reporting bias) |
Low risk |
Not observed |
Other bias |
Unclear risk |
Funding |