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. 2010 Feb 17;2010(2):CD006343. doi: 10.1002/14651858.CD006343.pub2

Maertens 2007.

Methods Multicentred, international (Belgium, Germany, Spain, US), doubled blind, randomised trial
Participants Paediatric patients (2 ‐ 17 years) with fever and neutropenia. Neutropenia was defined as ANC < 0.5x109/L. Pyrexia of unknown origin was defined as 96 hours of fever > 38°C not responding to broad‐spectrum antibacterial therapy
Interventions Caspofungin versus liposomal amphotericin B
Patients were enrolled in a 2:1 fashion comparing caspofungin (70mg/m2 on day 1 followed by 50mg/m2) with liposomal amphotericin B (Ambisome® 3mg/kg/day). An increase to caspofungin 70 mg/m2 (maximum 70 mg daily) or liposomal amphotericin B 5 mg/kg was allowed after 5 days. The period of follow up was 7 days following completion of therapy
Outcomes Primary endpoint: the proportion of patients with more than one drug‐related adverse event during the study period and 14 days post‐therapy
Secondary endpoints: drug‐related serious adverse events, discontinuation due to drug‐related adverse events and proportion of patients with a favourable overall efficacy outcome based on a five‐part composite endpoint (Walsh 2004a). Treatment was judged to be successful if all of the following criteria were met: i) successful treatment of any baseline fungal infection, ii) absence of any breakthrough fungal infection during therapy or within seven days after the completion of therapy, iii) survival for seven days after the completion of therapy, iv) no premature discontinuation of study therapy because of drug related toxicity or lack of efficacy, and v) resolution of fever (defined as a temperature below 38°C for at least 48 hours) during neutropenia.
Notes Paediatric population only (range: 2 to 17 years).
Authors contacted for further data (3/12/2008). Data was only available in abstract form.
Some absolute numbers are not yet published so therefore for pooled analyses, some absolute numbers were calculated from percentages.
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk Unclear from the abstract although it is likely to be adequate as the study was modelled on Walsh 2004a.
Allocation concealment? Unclear risk Unclear from the abstract although it is likely to be adequate as the study was modelled on Walsh 2004a.
Blinding? 
 All outcomes Low risk Patients and investigators were blinded to the treatment administered.
Incomplete outcome data addressed? 
 All outcomes Unclear risk Patients enrolled: 82 patients. One patient had no screening temperature above 38°C. Modified Intention to treat population: 81 patients. Five patients received < 4 days of study therapy, 1 patient received concomitant antifungal therapy and 14 patients had other protocol violations. Evaluable‐patient population: 65 patients.
Free of selective reporting? Unclear risk All expected outcomes are included in the abstract however full data was not available.
Free of other bias? Unclear risk The study appears to be free from other sources of bias although only published in an abstract form.