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. 2014 Jul 28;2014(7):CD003772. doi: 10.1002/14651858.CD003772.pub4

Chong 2003.

Methods

  • Study design: parallel RCT

  • Study duration: January 2000 to May 2001

  • Duration of follow‐up: 3 months

  • Power calculation: 220 to show 10% difference in UTI cure with 80% power
Participants

  • Country: Singapore

  • Setting: tertiary centre IP

  • Children aged I month to 13 years; UTI confirmed on 2 clean catch urine samples (single organism > 100,000/mL) or 1 catheter specimen (single organism > 1,000/mL)

  • Number: treatment group 1 (84); treatment group 2 (88)84 (40F)

  • Mean age ± SD (years): treatment group 1 (0.95 ± 1.25); treatment group 2 (0.90 ± 1.36)

  • Sex (M/F): treatment group 1 (44/40); treatment group 2 (41/47)

  • VUR: treatment group 1 (21, 11 no MCU); treatment group 2 (21, 15 no MCU)

  • Exclusion criteria: known obstructive uropathy; aminoglycoside or other nephrotoxic agent in previous month; allergy to aminoglycoside; renal or hearing impairment (including abnormal baseline OAE)
Interventions Treatment group 1

  • IV gentamicin: 5 mg/kg/d daily till resolution of fever (3.7 ±1.8 days)


Treatment group 2

  • IV gentamicin: 6 mg/kg/d 8 hourly till resolution of fever (3.5 ± 1.8 days)
Outcomes

  • Negative urine culture at end of gentamicin

  • Time to resolution of fever

  • Nephrotoxicity (increase in creatinine by 50% or more)

  • Ototoxicity (loss of 30 dB or more on repeat OAE test and confirmed on brain auditory evoked response

  • Kidney scars on DMSA scan at 3 months
Notes

  • Definition of UTI: fever > 38°C, pyuria > 200/mL or offensive urine, dysuria, frequency, loin pain

  • Post randomisation exclusions: No UTI (23), protocol violation (10), abnormal baseline OAE hearing test

  • 38/210 excluded from analysis: no UTI (23); resistant to gentamicin (1); abnormal baseline hearing (4); protocol violation (10)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information provided
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding. Lack of blinding could influence clinical assessment
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk No blinding but primary outcome was a laboratory result (negative urine culture) and unlikely to influenced by lack of blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 15 (8%, excluding patients without UTI) were excluded from analysis (not including patients without UTI). This is unlikely to influence results
Selective reporting (reporting bias) Low risk Expected outcomes reported
Other bias Low risk Funded by KK Women's and Children's Hospital RAU Grant 029/1999