Walsh 1999.
Methods | Multicentred, national (US), doubled‐blind, randomised trial | |
Participants | Paediatric and adult patients with fever and neutropenia. Neutropenia was defined as ANC < 0.5x109/L. Pyrexia of unknown origin was defined as 120 hours of fever > 38°C not responding to broad‐spectrum antibacterial therapy | |
Interventions | Liposomal amphotericin B versus conventional amphotericin B Liposomal amphotericin B (Ambisome® 3mg/kg/day) was compared with conventional amphotericin B (1mg/kg/day). Patients received study drug until recovery from neutropenia. The period of follow up was 7 days following after completion of therapy |
|
Outcomes | Primary endpoint: the proportion of patients with favourable overall efficacy outcome based on a five‐part composite endpoint: i) survival for seven days after initiation of the study drug, ii) resolution of fever during the period of neutropenia, iii) successful treatment of baseline fungal infection, iv) the absence of breakthrough fungal infection during therapy or within seven days after the completion of therapy and v) absence of premature discontinuation of the study drug because of toxicity or lack of efficacy Secondary endpoints: all‐cause mortality and adverse events including severe adverse events and drug related adverse events |
|
Notes | Paediatric and adult population (age 2 to 80 years). Authors contacted for further data (17/11/2008). Further data was received (13/3/2008). |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | Randomisation was achieved by computer generated system. |
Allocation concealment? | Low risk | Central allocation prevented patients and investigators from identifying assignment. |
Blinding? All outcomes | Low risk | All patients, investigators, industrial sponsors and study coordinators were blinded to the treatment administered. |
Incomplete outcome data addressed? All outcomes | Low risk | Patients enrolled: 702 patients, intention‐to‐treat population: 687 patients. The reason for the exclusion of 15 patients from the intention to treat population is not clear. All patients in the intention to treat population were included in the assessment of efficacy and toxicity. |
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. |