Skip to main content
. 2019 Apr 1;2019(4):CD001534. doi: 10.1002/14651858.CD001534.pub4

Brendstrup 1990.

Methods

  • Study design: parallel RCT

  • Duration of study: 1982 to 1986

  • Duration of follow‐up: 6 months
Participants

  • Country: Denmark

  • Setting: multicentre (7)

  • Children with UTI in the previous year were included; stratified by urography

    • VUR: 30; abnormal urography: 30

  • Number (analysed/randomised): 120/130; treatment group 1 (67/60); treatment group 2 (63/60)

  • Mean age (range): 7.5 years (1 to 14)

  • Sex (M/F): 4/126

  • Exclusion criteria: SCr > 120 μmol/L; myelomeningocele; obstruction to flow; immunodeficiency; allergic reactions to nitrofurantoin or TMP; concomitant antibiotic treatment
Interventions Treatment group 1

  • Nitrofurantoin: 1 to 1.5 mg/kg for a mean of 5.6 months


Treatment group 2

  • TMP: 2 to 3 mg/kg for a mean of 5.9 months
Outcomes

  • Number of repeat infections/group

  • Number of children who discontinued antibiotics due to adverse reactions
Notes

  • Urine screened every month and if the child developed symptoms. Discussion states they did not record symptoms so cannot distinguish between asymptomatic UTI and symptomatic UTI

  • Separate outcomes for abnormal urography, reflux and normal children presented in paper

  • 10 children withdrew from study prior to 1st urine collection; nitrofurantoin (7); TMP (3)

  • Initial UTI defined a clean‐catch midstream urine > 100,000 CFU/mL

  • Funding source: "The Danish Medical Research Council (no. 5521 11 1 and no. 5521486)"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Does not state how sequence was generated
Quote: "randomised by the local hospital"
Allocation concealment (selection bias) Low risk Allocation by external group
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Two antibiotics were delivered in indistinguishable mixtures, suggests blinding
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk 7/60 in nitrofurantoin group, and 3/60 in trimethoprim group excluded from analysis, only included in the evaluation of side effects
Selective reporting (reporting bias) High risk Primary outcome is positive culture rather than symptomatic UTI
Other bias Unclear risk Insufficient information to permit judgement