CSG 1991.

Methods	Study design: parallel RCT Study period: NS
Participants	Inclusion criteria Setting/recruitment: 10 hospital paediatric departments in and around Copenhagen Country: Denmark Children aged 1 to 15 years with clinical symptoms requiring immediate treatment, significant bacteriuria defined as ≥ 105 cfu/mL of a single bacterium in a clean catch mid‐stream urine sample. Bag samples of urine were not accepted Number: 359 randomised, 264 analysed; 168 included in this review Treatment group: 90 Control group: 78 Sex (M/F): All female Exclusion criteria Antibiotic treatment one week prior to inclusion; suspicion of allergy to penicillin or sulfonamides; required parenteral antibiotic treatment; fever > 39°C or impaired general condition; SCr > 120 µmol/L; known severe urinary tract malformations; immunosuppressive treatment or known immunodeficiency
Interventions	Treatment group Pivmecillinam, 20‐40 mg/kg/d in 2 doses for 3 days Control group Sulfamethizole, 40‐80 mg/kg/d in 2 doses for 10 days
Outcomes	Persistent bacteriuria (1‐10 days following treatment)
Notes	Children included had no previous UTI (17%), a history of UTI (31%), or recurrent UTI (52%) Another intervention arm was included in this study, 3‐day sulfamethizole. A Cochrane review by Michael 2003 reports outcomes for this comparison which is not repeated in this review. Source of funding: Danish Medical Research Council (5.52.11.10 and 5.52.14.86)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	To ensure an equal number of patients in each group, a block randomisation method was used. Randomisation was in blocks of 6 within each of the 10 participating departments. No details about the way the block randomisation was performed were reported.
Allocation concealment (selection bias)	Low risk	Allocation concealed by drawing consecutively numbered sealed envelopes prepared by the manufacturer
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	36 children did not fulfil inclusion criteria (26 bacteriuria not significant, 10 provided bag sample); treatment was discontinued in 6 children before scheduled; 32 children did not have urine cultures completed within 10 days from treatment; 2 children were not evaluated for other reasons; 19 boys were excluded because of the small number and because they were not evenly distributed between groups. The side effects of the 95 children who were not analysed were included as they received treatment.
Selective reporting (reporting bias)	Low risk	Planned outcomes were all analysed