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

PRIVENT 2009.

Methods

  • Study design: parallel RCT

  • Duration of study: December 1998 to March 2007

  • Duration of follow‐up:
Participants

  • Country: Australia

  • Setting: multicentre (4 sites)

  • Children from birth to 18 years with one or more symptomatic and microbiologically proven UTI; any grade of VUR (243 with VUR)

  • Number: treatment group (288); control group (288)

  • Median age (months): treatment group (13.1); control group (14.5)

  • Sex (M/F): treatment group (105/183); control group (102/186)

  • Exclusion criteria: known neurologic, skeletal, or urologic predisposing cause or known contraindication to TMP/SMX
Interventions Treatment group

  • TMP/SMX: 2/10 mg/kg/day for 12 months


Control group

  • Colour and taste matched placebo in the same volume for 12 months
Outcomes

  • Symptomatic UTI within 12 months

  • Febrile UTI

  • Hospitalisation for UTI

  • Hospitalisation for non‐UTI illnesses

  • Deterioration of parenchyma, detected by DMSA
Notes

  • Review authors are investigators and authors on this trial ‐ data was extracted by an independent person

  • Funding source: "Supported by grants from the National Health and Medical Research Council of Australia (990735, 301999, and 402764) and from the Financial Markets Foundation for Children of Australia (058‐2003) and by a private donation by J.T. Honan of the Manildra Group"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Sequence generated by external, independent facility
Allocation concealment (selection bias) Low risk Externally managed without the possibility of interference from patients, parents, health care providers or researchers
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Patients, carers, clinicians and research staff blind to treatment allocation
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Clinical symptoms, urine culture and DMSA results read blind to treatment allocation. Statistical analysis completed blind to treatment group
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patients accounted for and detailed, 4/288 in antibiotic arm and 8/288 in placebo arm lost to follow‐up. Included in denominator of analyses
Selective reporting (reporting bias) Low risk Primary outcome appropriate, secondary outcomes detailed
Other bias Low risk Methods and patient descriptors reported in good detail