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. 2015 Apr 8;2015(4):CD009534. doi: 10.1002/14651858.CD009534.pub2

Giamarellou 1998.

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

  • Inclusion criteria: men and women ≥ 65 years; freely voiding; asymptomatic; strain susceptible to ofloxacin

    • Definition of ASB: ≥ 100,000 CFU/mL urine specimens twice within 1 week, same pathogen

  • 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
  • Ofloxacin: 200 mg twice/d for 3 days; 200 mg/d for a total of 3 months (87 tablets/person)


Treatment group 2
  • Ofloxacin: 200 mg twice/d for 3 days fortnightly for a total of 3 months (36 tablets/person)


Control group
  • No treatment

Outcomes
  • Overall mortality

  • Bacteriological cure at 3 and 6 months

    • Definition bacteriological cure: < 1000 CFU/mL throughout treatment and after 3 months of follow‐up (at 6 months) for those who completed treatment

  • 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