Queiroz‐Telles 2008.
Methods | Multicentred, international (Europe, North and South America, Thailand, India) double‐blind randomised trial (a substudy of the larger study inclusive of adults and children) | |
Participants | Paediatric patients (0 ‐ 16 years) with candidaemia or Invasive candidiasis | |
Interventions | Micafungin versus liposomal amphotericin B. Micafungin was administered at a daily dose of 2 mg/kg of body weight for patients who weighed ≤40 kg and 100 mg for patients who weighed >40 kg. Liposomal amphotericin B was administered at a daily dose of 3 mg/kg of body weight. The recommended minimum duration of study drug therapy was 14 days. The period of follow up was 12 weeks | |
Outcomes | Primary endpoint: treatment success which included both clinical and mycological endpoints. Clinical response was defined as a complete or partial resolution of signs and symptoms, and mycologic response was defined as eradication or presumed eradication Secondary endpoints: all‐cause mortality, IFI‐related mortality, toxicities |
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Notes | Paediatric population only (range: 0 to 16 years). Neonates could not be excluded for mortality and toxicity endpoints and so have been included in the analysis. Authors contacted for further data (17/11/2008). No further data were available. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | Randomisation was achieved by computer generated system and stratified by centre and baseline neutropenic status. |
Allocation concealment? | Low risk | Central allocation prevented patients and investigators from identifying assignment. |
Blinding? All outcomes | Low risk | Patients and investigators were blinded to the treatment administered. Preparation of the study drug infusion bottle and changes in dose were managed by an unblinded staff member of the centre, and an unblinded study monitor reviewed drug accountability records. |
Incomplete outcome data addressed? All outcomes | Low risk | Patients enrolled: 109 patients. Three patients did not receive any drug. Intention to treat population: 106 patients. Eight patients did not have candidaemia infection confirmed. Modified intention to treat population: 98 patients. |
Free of selective reporting? | Low risk | All expected outcomes were included in the report. |
Free of other bias? | Low risk | The study appeared to be free from other sources of bias. |