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. 2019 Apr 1;2019(4):CD001534. doi: 10.1002/14651858.CD001534.pub4

Baciulis 2003.

Methods
  • Study design: parallel open‐label RCT

  • Duration of study: 2000 to 2002

  • Follow‐up: 6 months

Participants
  • Country: Lithuania

  • Setting: single centre

  • Incidence of acute pyelonephritis acute > 2 times/year, acute or chronic pyelonephritis with urinary tract obstruction symptoms (e.g. hydronephrosis) or VUR, chronic latent cystitis

  • Number: treatment group 1 (15); treatment group 2 (18)

  • Mean age ± SD (years): treatment group 1 (8.4 ± 2.3); treatment group 2 (7.8 ± 3.5)

  • Sex (M/F): treatment group 1 (0/15); treatment group 2 (1/17)

  • Exclusion criteria: acute pyelonephritis without urinary tract obstruction characteristic; acute cystitis; source of infection agent Pseudomonas; cefadroxil allergic children; increased susceptibility to cephalosporins

Interventions Treatment group 1
  • Cefadroxil: 12.5 to 15 mg/kg every night for 6 months


Treatment group 2
  • Cefadroxil: 12.5 to 15 mg/kg on alternate nights for 6 months

Outcomes
  • Repeat positive urine culture

  • Adverse effect; nausea

  • Day/night time wetting

Notes
  • Translated from Lithuanian

  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study was described as randomised, method of randomisation was not reported
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk The paper does not clearly state whether more children were enrolled than are reported, so it is unclear whether there is any missing data
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias Unclear risk Insufficient information to permit judgement; funding source not reported