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. 2014 Jul 28;2014(7):CD003772. doi: 10.1002/14651858.CD003772.pub4

Banfi 1993.

Methods

  • Study design: parallel RCT

  • Study duration: 31 August 1989 to 16 November 1990

  • Duration of follow‐up: 4 to 6 weeks
Participants

  • Country: South America/Europe

  • Setting: multicentre; IP/OP

  • Symptomatic UTI including children with uncomplicated, complicated and upper UTI; aged: ≥ 12 years

  • Urine collection: clean catch, catheter, suprapubic

  • Number

    • Safety population/APN: treatment group 1 (154/52); treatment group 2 (74/21)

    • Efficacy population/APN: treatment group 1 (101/36); treatment group 2 (50/15)

  • Mean age, range (years)

    • Safety population: treatment group 1 (5.5, 0.25 to 12); treatment group 2 (5.1, 0.5 to 12)

    • Efficacy population: treatment group 1 (6.4, 0.5 to 12); treatment group 2 (6.0, 0.5 to 12)

  • Sex (M/F)

    • Safety population: treatment group 1 (35/119); treatment group 2 (18/56)

    • Efficacy population: treatment group 1 (17/84); treatment group 2 (7/43)

  • Uropathy: treatment group 1 (28); treatment group 2 (9)

  • 52 APN included in safety; 36 in efficacy

  • Exclusion criteria: Cystitis episodes < 3/year; persistent UTI with uropathy; infections likely to need treatments other than study drugs; antibiotics within last 2 weeks; other study drug in < 4 weeks; other serious illness; pregnant, nursing or not using contraceptives; kidney abscess; history of hypersensitivity.
Interventions Treatment group 1

  • Oral ceftibuten: 9 mg/kg/d (max 400 mg/d) for 10 days


Treatment group 2

  • Oral TMP/SMX: 8 mg/40 mg/kg/d (max 320/1600) for 10 days
Outcomes

  • Bacterial response at 5 to 9 days and 4 to 6 weeks after treatment completed

  • Clinical response at 5 to 9 days and 4 to 6 weeks after treatment completed

  • Adverse effects

  • Time to resolution of symptoms
Notes

  • Definition of APN not provided

  • 3/231 (1.3%) excluded from safety analysis. 80/231 (34.6%) excluded from efficacy (did not meet entry criteria (51); mis‐randomisation (6); efficacy data not available (18); other (5))
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Said to be randomly assigned. 2:1 ratio
Allocation concealment (selection bias) Unclear risk Said to be randomly assigned
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding and lack of blinding could influence clinical management
Blinding of outcome assessment (detection bias) 
 All outcomes High risk No blinding and lack of blinding could influence clinical outcome assessment
Incomplete outcome data (attrition bias) 
 All outcomes High risk 16% of total group excluded from analysis for reasons other than not meeting entry criteria and this could influence results
Selective reporting (reporting bias) Low risk Data reported on clinical & bacteriologic response & adverse effects
Other bias Unclear risk No information provided