International, open-label, noncomparative, clinical trial of micafungin alone and in combination for treatment of newly diagnosed and refractory candidemia
Abstract
Candida spp. are the fourth leading cause of bloodstream infections, and non-albicans species are increasing in importance. Micafungin is a new echinocandin antifungal agent with excellent in vitro activity against Candida spp. Pediatric, neonatal, and adult patients with new or refractory candidemia were enrolled into this open-label, noncomparative, international study. The initial dose of micafungin was 50 mg/d (1 mg/kg for patients <40 kg) for infections due to C. albicans and 100 mg/d (2 mg/kg for patients <40 kg) for infections due to other species. Dose escalation was allowed. Maximum length of therapy was 42 days. A total of 126 patients were evaluable (received at least five doses of micafungin). Success (complete or partial response) was seen in 83.3% patients overall. Success rates for treatment of infections caused by the most common Candida spp. were as follows: C. albicans 85.1%, C. glabrata 93.8%, C. parapsilosis 86.4%, and C. tropicalis 83.3%. Serious adverse events related to micafungin were uncommon. Micafungin shows promise as a safe and effective agent for the treatment of newly diagnosed and refractory cases of candidemia. Large-scale, randomized, controlled trials are warranted.
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Safety and tolerability were similar between the two groups and were consistent with the reported safety profile of echinocandin class drugs.
“Safety and tolerability were similar between the two groups and were consistent with the reported safety profile of echinocandin class drugs. 22-26”
Although interpretive breakpoints for amphotericin B have not been established, isolates of Candida for which MICs are >1 μg/ml are unusual and possibly 'resistant' or may require high doses of amphotericin B for optimal treatment.
“Although interpretive breakpoints for amphotericin B have not been established, isolates of Candida for which MICs are > 1 𝛍 g/ml are unusual and possibly 'resistant' or, at the very least, may require high doses of amphotericin B for optimal treatment (189, 253, 274).”
From Epidemiology of Invasive Candidiasis: a Persistent Public Health Problem (2007) · cites this paper as [189]
Despite the perception that amphotericin B and its analogs are broadly active against Candida species, evidence is accumulating that suggests less-than-optimal activity against a number of species.
“Thus, despite the perception that amphotericin B and its analogs are broadly active against Candida species, evidence is accumulating that suggests less-than-optimal activity against a number of species (189, 274).”
From Epidemiology of Invasive Candidiasis: a Persistent Public Health Problem (2007) · cites this paper as [189]
The triazole antifungal agents (fluconazole, itraconazole, voriconazole, and posaconazole) are safe and effective for the treatment of IC.
“The triazole antifungal agents (i.e., fluconazole, itraconazole, voriconazole, and posaconazole) are safe and effective for the treatment of IC (31, 32, 189, 274).”
From Epidemiology of Invasive Candidiasis: a Persistent Public Health Problem (2007) · cites this paper as [189]
Treatment guidelines recommend higher doses of amphotericin B (≥0.7 mg/kg/day for C. glabrata and 1 mg/kg/day for C. krusei) for these two species.
“These findings are reflected in the treatment guidelines for Candida infections, wherein higher doses of amphotericin B ( ≥ 0.7 mg/kg of body weight/day for C. glabrata and 1 mg/kg/day for C. krusei ) are recommended for these two species (189, 274).”
From Epidemiology of Invasive Candidiasis: a Persistent Public Health Problem (2007) · cites this paper as [189]
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References 50 · Cited by 189
- Authors
- Ostrosky-Zeichner, L., Kontoyiannis, D., Raffalli, J., Mullane, K. M., Vazquez, J., Anaissie, E. J., Lipton, J., Jacobs, P., Rensburg, J. H. J., Rex, J. H., Lau, W., Facklam, D., & Buell, D. N.
- Affiliations
- The University of Texas MD Anderson Cancer Center (US)
- New York Medical College (US)
- Loyola University Medical Center (US)
- University of Arkansas for Medical Sciences (US)
- Princess Margaret Cancer Centre (CA)
- AstraZeneca (United Kingdom) (GB)
- Astellas Pharma (United States) (US)
- Venue
- European Journal of Clinical Microbiology & Infectious Diseases
- Published
- 2005-10
- Volume
- 24
- Issue
- 10
- Pages
- 654-661
- ISSN
- 0934-9723 (ISSN-L)
- 1435-4373
- OpenAlex
- W2099536314
- Cited by
- 189
- References
- 50
- Citations by year
- 2026: 1 · 2025: 1 · 2022: 2 · 2021: 2 · 2020: 2 · 2019: 4 · 2018: 4 · 2017: 2 · 2016: 1 · 2015: 5 · 2014: 6 · 2013: 3 · 2012: 11
- FWCI
- 17.49
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- European Journal of Clinical Microbiology & Infectious Diseases (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Antifungal resistance and susceptibility
- Health Sciences › Medicine › Epidemiology › Fungal Infections and Studies
- Health Sciences › Medicine › Ophthalmology › Ocular Infections and Treatments
- Keywords
- micafungin, candidemia, Candida albicans, Candida glabrata, Candida parapsilosis, Candida tropicalis, non-albicans Candida, antifungal treatment efficacy, adverse events
- MeSH terms
- Micafungin, Adolescent, Adult, Antifungal Agents, Candida, Candidiasis, Child, Child, Preschool, Drug Therapy, Combination, Female, Humans, Infant, Infant, Newborn, Lipoproteins, Male, Peptides, Cyclic, Prospective Studies, Fungemia, Treatment Outcome, Internationality, Echinocandins, Lipopeptides
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