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

Carlsen 1985.

Methods
  • Study design: cross‐over RCT

  • Duration of study: not reported

  • Duration of follow‐up: 12 to 14 months

Participants
  • Country: Denmark

  • Setting: single centre

  • Children with either VUR (17 children) or a history of recurrent UTI defines as ≥ 3 episodes in 12 months or 2 episodes in 6 months (18 children)

  • Number: 35

  • Age: 1 to 13 years

  • Sex (M/F): 4/31

  • Exclusion criteria: previous intolerance to nitrofurantoin; VUR > grade 3

Interventions Treatment group 1
  • Pivmecillinam

    • 100 mg/d for children < 6 years

    • 200 mg/d for children > 6 years


Treatment group 2
  • Nitrofurantoin: 1.5 mg/kg/d


Cross‐over
  • 6 to 10 months for 1st antibiotic, crossed over to 2nd antibiotic for 6 months

Outcomes
  • Number of repeat positive urine cultures

  • Tolerance/side effects

  • Changes in faecal flora

Notes
  • Urine samples screened each visit

  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details reported
Allocation concealment (selection bias) Unclear risk States "randomly allocated' but no other details
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk Withdrawals detailed, 11/35 did not complete the study and were not analysed
Selective reporting (reporting bias) High risk Primary outcome is positive culture, not symptomatic UTI
Other bias Unclear risk Many details missing