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Micafungin versus caspofungin in patients with invasive candidiasis or candidaemia: a Phase III, randomised, double-blind, parallel group, non-inferiority study

Abstract number: 1732_84

Dupont B., De Waele J., Betts R., Rotstein C., Nucci M., Arnold L., Kovanda L., Wu C., Buell D.

Objectives: To determine the efficacy and safety of two doses of intravenous micafungin (MICA) versus caspofungin (CAS) as an antifungal treatment for patients with confirmed invasive candidiasis or candidaemia.

Methods: Patients aged ≥ 18 years with confirmed invasive candidiasis or candidaemia were randomised 1:1:1 to receive MICA 100 mg/day (MICA100), 150 mg/day (MICA150) or CAS (70 mg on day 1 and 50 mg/day thereafter). The primary efficacy endpoint was treatment success by investigators' assessment at the end of blinded intravenous therapy, defined as a positive clinical response and a positive mycological response. Patients who died during therapy or had missing values were considered treatment failures. Non-inferiority was defined as the lower bound of 95% CIs for treatment difference for MICA versus CAS exceeding -15%. Secondary efficacy endpoints included treatment success as assessed by the data review panel, clinical response, mycological response, incidence of emergent invasive fungal infections throughout the study and incidence of relapse post-treatment.

Results: The full analysis set (FAS) was the primary analysis set for efficacy and comprised 593 patients: 199 receiving MICA100, 202 receiving MICA150 and 192 receiving CAS. Overall treatment success was seen in 73.9% of MICA100, 70.3% of MICA150 and 71.4% of CAS patients. The two-sided 95% CIs exceeded the predefined non-inferiority margin of -15%; both MICA doses were therefore non-inferior to CAS. The data review panel assessments confirmed this result. On secondary efficacy endpoints, the three treatment arms were similar in terms of clinical and mycological response, and there were no significant differences in the incidence of emergent fungal infections during the study and in the incidence of relapse post-treatment. There were no clinically significant differences between the three treatment arms in terms of adverse events, including those of special interest, such as hepatic and renal function adverse events. The incidence of death during treatment was similar across treatment groups.

Treatment successMICACAS
100 mg150 mg 
Overall, n (%)147/199 (73.9)142/202 (70.3)137/192 (71.4)
Treatment difference vs. caspofungin, % (95% CIa)2.5 (-5.9, 11.0)-1. 1 (-9. 3, 7.8) 
aAdjusted for baselin APACHE Il score and geographic region.

Conclusion: MICA100 and MICA150 were equally effective and were non-inferior to CAS on the primary efficacy endpoint of treatment success as defined by the investigator. There were no significant differences between the MICA treatment arms and CAS on all secondary endpoints. All three treatment regimens had similar safety profiles.

Session Details

Date: 31/03/2007
Time: 00:00-00:00
Session name: European Society of Clinical Microbiology and Infectious Diseases
Subject:
Location: ICC, Munich, Germany
Presentation type:
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