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

Antachopoulos 2016.

Methods
  • Study design: cross‐over RCT

  • Duration of study: not reported

  • Duration of follow‐up: 1 year

Participants
  • Country: Greece

  • Setting: single centre

  • Children aged 1 month to 5 years recruited after hospitalisation for first febrile UTI; indications for prophylaxis included VUR, anatomical abnormalities of urinary tract and neurogenic bladder

  • Mean age (range): 13.6 months (1 to 60 months)

  • Sex (M/F) 54/43

  • Exclusion criteria: G6PD deficiency; allergy to cotrimoxazole or cephalosporins; congenital or acquired immunodeficiency; already on prophylactic antibiotics

Interventions Treatment group 1
  • TMP: 2 mg/kg once daily at night for 6 months


Treatment group 2
  • Cefuroxime axetil (10 mg/kg), cefprozil (10 mg/kg), or cefaclor (15 mg/kg) for 6 months

Outcomes
  • Prevalence of repeat UTI

  • Time to break through UTI

  • Bacterial sepsis

  • Resistance to antibiotics used

Notes
  • Data could not be included in analyses, not separated into first cross‐over

  • Data were reported as number of courses of antibiotics, not children

  • Funding source: "This study was not funded by any source"

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk States "randomized at a ratio of 1:1”, method of randomisation not reported
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
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 Unclear risk Unable to determine numbers because reported as courses of antibiotics, not children
Selective reporting (reporting bias) High risk Appropriate outcomes but unable to use data as results reported as courses of antibiotics, not children
Other bias Unclear risk Many details missing and few descriptives of included children