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

Belet 2004.

Methods
  • Study design: parallel RCT

  • Duration of study: 1998 to 2000

  • Duration of follow‐up: 6 months

Participants
  • Country: Turkey

  • Setting: single centre

  • Children with recurrent UTI and no underlying urinary pathology; no definitions of UTI; urine samples screened at visits; no children with VUR

  • Number: treatment group 1 (21); treatment group 2 (25); treatment group 3 (34)

  • Mean age ± SE (years): treatment group 1 (7.7 ± 0.9); treatment group 2 (4.3 ± 0.7); treatment group 3 (4.4 ± 0.6)

  • Sex (M/F): treatment group 1 (4/17); treatment group 2 (7/18); treatment group 3 (2/32)

  • Exclusion criteria: not reported

Interventions Treatment group 1
  • TMP/SMX: 1 to 2 mg/kg for 3 months


Treatment group 2
  • Cefadroxil: 5 mg/kg for 3 months


Treatment group 3
  • Cefprozil: 5 mg/kg for 3 months

Outcomes
  • Repeat symptomatic UTI

  • Asymptomatic UTI

  • Adverse reactions

Notes
  • 20 excluded after randomisation: TMP/SMX (12); cefadroxil (8) (did not come to check‐ups or did not use the drug regularly during prophylaxis)

  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details of how sequence was generated, states randomised by drawing lots
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
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 Low risk No missing data evident, no losses during follow‐up reported
Selective reporting (reporting bias) Low risk Primary outcome is appropriate
Other bias High risk Age of TMP/SMX group was significantly higher than the other two groups