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

Boscia 1987.

Methods
  • Study design: parallel RCT

  • Duration of study: July 1983 to July 1985

  • Duration of follow‐up: 6 months

Participants
  • Country: USA

  • Setting: geriatric centre

  • Inclusion criteria: elderly ambulatory women capable of giving a midstream clean‐catch urine specimen

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

  • Number: treatment group (63); control group (61)

  • Mean age ± SE (years): treatment group (85.8 ± 0.9); control group (85.8 ± 0.7)

  • Sex (M/F): all women

  • Exclusion criteria: indwelling catheter; unable to care for themselves

Interventions Treatment group
  • Initial treatment (depending on susceptibility of pathogen)

    • TMP: 200 mg single dose

    • Cefaclor 500 mg 3 times/d for 3 days

  • Retreatment (for failure)

    • TMP: 200 mg twice/d for 14 days

    • Cefaclor: 500 mg 3 times/d for 14 days


Control group
  • No treatment

Outcomes
  • Morbidity

  • Mortality

  • Bacteriological cure

    • Definition of bacteriological cure: < 10,000 CFU/mL

Notes
  • Urine culture 2 weeks post treatment and at 6 months

  • Most E. coli

  • Monitored for symptoms, mortality, adverse events, antibiotic treatment, bladder catheterization

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised from code numbers prior to urine culture
Allocation concealment (selection bias) Low risk Assigned by an individual not associated with the study
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Single blind
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Exclusions, drop‐out described: treatment group (died (2); incontinent (3); moved away (2); refused (1)); control group (3 died (3); incontinent (2); refused (1))
Selective reporting (reporting bias) Low risk Not observed
Other bias Low risk Not observed