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

Liern 2011.

Methods
  • Study design: open‐label parallel RCT

  • Duration of study: not reported

  • Duration of follow‐up: 12 months

Participants
  • Country: Argentina

  • Setting: single centre

  • Children > 3 years; history of recurrent UTI; toilet trained with no uropathy; normal creatinine; normal renal ultrasound; no antibiotic prophylaxis in past 6 months

  • Number: treatment group (26); control group (24)

  • Mean age (range): 4.6 years (3 to 7 years)

  • Sex (M/F): treatment group (8/18); control group (11/13)

  • Exclusion criteria: pyelonephritis with scarring; VUR; synechiae phimosis; non‐corrected labia minora

Interventions Treatment group (one of 3 antibiotics)
  • TMP/SMX: 2 mg/kg once/night OR

  • Nitrofurantoin: 2 mg/kg once/night OR

  • Cephalexin: 25 mg/kg once/night


Control group
  • No treatment, monthly urine sample tests

Outcomes
  • Incidence rate of UTI

  • Month of UTI episode

  • Correlation coefficients with predisposing factors

  • No data on adverse events or microbial resistance

Notes
  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was performed using the statistical program EPIDAT.3.0, creating two groups
Allocation concealment (selection bias) Low risk Allocation was unlikely to be manipulated but treatment arm was known
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk 8/58 lost to follow‐up, no data given
Selective reporting (reporting bias) High risk Unclear reporting of repeat symptomatic UTIs
Other bias Unclear risk Translation is imperfect and might contribute to uncertainty in details