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

Smellie 1978.

Methods

  • Study design: open‐label, parallel RCT

  • Duration of study: not reported

  • Duration of follow‐up: 2 years
Participants

  • Country: UK

  • Setting: single centre

  • Children with bacteriologically proven symptomatic UTIs; initial UTI defined by urine culture, but no CFU given

  • Number: treatment group 1 (13); treatment group 2 (12); control group (22)

  • Age range: 2 to 12 years

  • Sex (M/F): treatment group 1 (2/11); treatment group 2 (2/10); control group (1/21)

  • VUR: none

  • Exclusion criteria: not reported
Interventions Treatment group 1

  • Low dose cotrimoxazole

    • SMX: 10 mg/kg/d for 6 to 12 months

    • TMP: 2 mg/kg/d for 6 to 12 months


Treatment group 2

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


Control group

  • No treatment
Outcomes

  • Number of repeat infection per group, asymptomatic reported as well as symptomatic
Notes

  • Use events within 10 months since treatment was 6 to 12 months and on average 10 months.

  • Follow‐up extended after treatment, ignore events in post‐treatment period. Assume 1 asymptomatic UTI occurred by 6 months

  • Funding source: "This study was supported by a grant from the Medical Research Council"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study was described as randomised, method of randomisation was not reported
Allocation concealment (selection bias) Unclear risk Treatment allocation know to clinician, possibly manipulatable more children with a history of prior UTIs received prophylaxis
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Treatment allocation was known to clinician
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Losses to follow‐up detailed
Selective reporting (reporting bias) Low risk Reports asymptomatic and symptomatic UTI just can't tell in what time frame the single asymptomatic UTI occurred
Other bias Unclear risk Many methods details are not detailed