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. 2019 Apr 1;2019(4):CD001534. doi: 10.1002/14651858.CD001534.pub4

Lettgen 2002.

Methods
  • Study design: parallel, open‐label RCT

  • Duration of study: not reported

  • Duration of follow‐up: 6 to 12 months

Participants
  • Country: Germany

  • Setting: single centre

  • Girls with at least 2 UTIs in the last 12 months

  • Number (analysed/randomised): treatment group 1 (27/29); treatment group 2 (30/31)

  • Age range: 1 to 11 years

  • VUR: not reported

  • Exclusion criteria: existing UTI or < 2 UTIs within the previous year; pyelonephritis; urolithiasis; neurogenic bladder; urinary tract obstruction

Interventions Treatment group 1
  • Cefixime: 2 mg/kg for 6 to 12 months


Treatment group 2
  • Nitrofurantoin: 1 mg/kg for 6 to 12 months

Outcomes
  • Number of repeat clinical infections (not all culture verified)

  • Number of children who experienced adverse reactions of treatment

Notes
  • Initial UTI diagnosed by MSU > 100,000 CFU/mL

  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk External to investigators, managed by department of statistics university clinic
Allocation concealment (selection bias) Unclear risk Allocation managed by department and examining physician
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 2/60 lost to follow‐up accounted for
Selective reporting (reporting bias) High risk Primary outcome is clinical diagnosis, not all were culture verified
Other bias Unclear risk Many methodological details missing, uncertain of other biases