Montini 2008.

Methods	Study design: open‐label parallel RCT Duration of study: May 2000 to August 2006 Duration of follow‐up: 12 months
Participants	Country: Italy Setting: multicentre (22 sites) Children with normal kidney function and 1st febrile UTI, pyuria ≥ 25 cells/µL on 2 consecutive urine samples and urine culture 1 organism ≥ 108 CFU/L on 2 consecutive bag samples; 2 urinalysis results had to be concordant; symptoms had to at least 2 of: fever > 38°C, ESR > 30 mm in 1 standard hour or CRP ≥ 3 times upper limit of normal and neutrophil count above normal Number: treatment group (127); control group (211) Mean age ± SD (months): treatment group (14.7 ± 15.5); control group (14.7 ± 15.5) Sex (M/F): treatment group (37/90); control group (67/144) Exclusion criteria: complex urologic malformations, and/or severe renal damage (DMSA < 30% relative function).
Interventions	Treatment group 1 Cotrimoxazole or co‐amoxiclav: 15 mg/kg/d for 12 months Control group No treatment
Outcomes	Repeat febrile UTI Repeat positive urine culture
Notes	Funding source: "This study was supported by Region of Veneto (research project 40/01) and association Il Sogno di Stefano (Stephen’s Dream)."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated by the coordinating centre
Allocation concealment (selection bias)	Low risk	Allocation unable to be manipulated
Blinding of participants and personnel (performance bias) All outcomes	High risk	Unblinded, open label
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Unsure for UTI, DMSA scans read blind to treatment
Incomplete outcome data (attrition bias) All outcomes	Low risk	Lost to follow‐up accounted for (10/127 and 16/211)
Selective reporting (reporting bias)	Low risk	Primary outcome appropriate
Other bias	Low risk	Well reported study