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. 2012 Aug 15;2012(8):CD006857. doi: 10.1002/14651858.CD006857.pub2

Wallen 1983.

Methods
  • Study design: parallel RCT

  • Study period: NS

Participants Inclusion criteria
  • Setting/recruitment: outpatients, The Children's Memorial Hospital, Chicago

  • Country: USA

  • Girls aged 1 year to 12 years with suspected UTI and significant bacteriuria defined as ≥ 105 cfu/mL E. coli organisms in 2 clean catch or urine collection bag samples.

  • Median age: 5.45 years

  • Number: 54 randomised, 49 analysed

    • Treatment group: 26

    • Control group: 25


Exclusion criteria
  • Clinical symptoms of pyelonephritis (including fever > 38.3ºC, flank pain, chills, ESR >21 mm/h); previous UTIs; antibiotic use during the week prior to the study; known urinary tract abnormalities

Interventions Treatment group
  • Single‐dose intramuscular amikacin sulfate 7.5 mg/kg (to a maximum of 240 mg)


Control group
  • 10‐day sulfisoxazole 150 mg/kg/day in 4 divided doses

Outcomes
  • Persistent bacteriuria (2‐4 days following treatment)

  • Recurrence (30‐40 days following treatment)

Notes
  • Re‐infection rates were presented, but were only available for the single‐dose amikacin group; these rates have not been reported in this review.

  • Source of funding: NS

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random numbers table
Allocation concealment (selection bias) Unclear risk Not reported
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes High risk At the 2‐4 day follow‐up, 6 girls were lost to follow‐up. By the 30‐40 day follow‐up, 10 girls were lost to follow‐up.
Selective reporting (reporting bias) Low risk All planned outcomes were reported

BUN ‐ blood urea nitrogen; CRP ‐ C‐reactive protein; ESR ‐ erythrocyte sedimentation rate; NS ‐ not stated; SCr ‐ serum creatinine; SMX ‐ sulfamethoxazole; TMP ‐ trimethoprim; UTI ‐ urinary tract infection