Abstract | BACKGROUND: METHODS: This was an international, randomized, double-blind trial comparing micafungin (100 mg daily) and micafungin (150 mg daily) with a standard dosage of caspofungin (70 mg followed by 50 mg daily) in adults with candidemia and other forms of invasive candidiasis. The primary end point was treatment success, defined as clinical and mycological success at the end of blinded intravenous therapy. RESULTS: A total of 595 patients were randomized to one the treatment groups and received at least 1 dose of study drug. In the modified intent-to-treat population, 191 patients were assigned to the micafungin 100 mg group, 199 to the micafungin 150 mg group, and 188 to the caspofungin group. Demographic characteristics and underlying disorders were comparable across the groups. Approximately 85% of patients had candidemia; the remainder had noncandidemic invasive candidiasis. At the end of blinded intravenous therapy, treatment was considered successful for 76.4% of patients in the micafungin 100 mg group, 71.4% in the micafungin 150 mg group, and 72.3% in the caspofungin group. The median time to culture negativity was 2 days in the micafungin 100 mg group and the caspofungin group, compared with 3 days in the micafungin 150 mg groups. There were no significant differences in mortality, relapsing and emergent infections, or adverse events between the study arms. CONCLUSIONS:
|
Authors | Peter G Pappas, Coleman M F Rotstein, Robert F Betts, Marcio Nucci, Deepak Talwar, Jan J De Waele, Jose A Vazquez, Bertrand F Dupont, David L Horn, Luis Ostrosky-Zeichner, Annette C Reboli, Byungse Suh, Raghunadharao Digumarti, Chunzhang Wu, Laura L Kovanda, Leah J Arnold, Donald N Buell |
Journal | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
(Clin Infect Dis)
Vol. 45
Issue 7
Pg. 883-93
(Oct 01 2007)
ISSN: 1537-6591 [Electronic] United States |
PMID | 17806055
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Antifungal Agents
- Echinocandins
- Lipopeptides
- Lipoproteins
- Peptides, Cyclic
- Caspofungin
- Micafungin
|
Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Antifungal Agents
(administration & dosage)
- Candidiasis
(drug therapy)
- Caspofungin
- Dose-Response Relationship, Drug
- Double-Blind Method
- Echinocandins
- Female
- Fungemia
(drug therapy)
- Humans
- Lipopeptides
- Lipoproteins
(administration & dosage)
- Male
- Micafungin
- Middle Aged
- Peptides, Cyclic
(administration & dosage)
- Treatment Outcome
|