Komoroski 1999.

Methods	Study design: parallel RCT Study period: NS
Participants	Inclusion criteria Setting/recruitment: outpatient and emergency department, Arkansas Children's Hospital Country: USA Children aged 1 to 19 years with at 1 or more clinical symptoms of cystitis (including frequency, dysuria, enuresis, haematuria, pyuria, suprapubic tenderness) and significant bacteriuria defined > 104 cfu/mL of a single organism from 1 catheterized bladder specimen or >105 cfu/mL from a nitrite‐positive specimen. Urine cultures were also considered positive if > 105 cfu/mL of a single organism was obtained from a single clean‐catch specimen, and the second specimen contained organisms of the same in vitro sensitivity pattern as the first specimen. Number: 93 randomised, 59 analysed Treatment group: 36 Control group: 23 Exclusion criteria Pregnancy; antibiotic therapy in the previous 2 weeks; concomitant infection requiring additional antibiotic therapy; known renal or urologic problems that could predispose to a UTI; signs and symptoms of pyelonephritis (ill or toxic appearance, flank pain, costovertebral angle tenderness, or temperature ≥ 38.3ºC); history of hypersensitivity to cephalosporins or penicillin; a significant history of gastrointestinal, hematologic, hepatic, psychiatric, or central nervous system disease; history of drug or alcohol abuse; history of sexual abuse as a child; a parent or guardian who was unable to understand or follow instructions; a family situation in which follow‐up could not be assured; or refusal to obtain a catheterized sample, if necessary.
Interventions	Treatment group Single intramuscular ceftriaxone 50 mg/kg (to a maximum of 500 mg) 27 received ceftriaxone (500 mg); 9 received ceftriaxone (250 mg) Control group TMP‐SMX 4‐5 mg/kg twice daily for 10 days 22 received TMP‐SMX; 1 patient received amoxicillin because of sulfa hypersensitivity
Outcomes	Persistent bacteriuria (10‐30 days following treatment) Persistent bacteriuria and symptoms (10‐30 days following treatment)
Notes	Nine patients receiving ceftriaxone 250 mg were excluded from this analysis. It appears the study was originally designed to investigate ceftriaxone 250 mg versus control. The ceftriaxone 500 mg groups was added at a later date. When high treatment failures were reported, the 250 mg group was discontinued. The ceftriaxone 250 mg group is not reported as part of this review; using block randomisation, the groups should be of equal size. It does not seem logical that only 9 children were allocated to the ceftriaxone 250 mg group when more than double this number were allocated to the other 2 groups. Numbers reported in the text do not match the numbers reported in the tables. Numbers reported in tables have been used for this review. Source of funding: Roche Laboratories Inc.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	High risk	Open label study
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	It appears that children were randomised to treatment before the inclusion/exclusion criteria were applied. 23 children had urine cultures that showed no significant growth; 8 children had a laboratory or procedural error occurred (e.g., urinalysis obtained but culture not done, organisms in culture not worked up); 3 children did not return for follow‐up assessment
Selective reporting (reporting bias)	Unclear risk	Relapse and recurrence were reported, but not in a format suitable for data extraction for this review.