Objectives: Micafungin (MCFG) has been approved in Japan for treatment of fungemia and invasive infections caused by Candida and Aspergillus. To our knowledge, there are no reports that evaluated the effects of MCFG treatment in the areas of surgery, emergency, and intensive care medicine. We therefore studied its efficacy and safety in patients with fungal infection in a multicentre study. Methods: The study was conducted from July 2003 to March 2005 in patients with a fever of 37.5Â°C or higher, who met any of the following criteria as the rationale for the diagnosis: #1 Patients with a causative fungus identified by mycological or pathological examination; #2 Patients with fungi detected at multiple sites by surveillance culture or with a positive beta-D-glucan test. Patients who met requirement #2 had to have a high risk factor for the development of systemic fungal infection. Patients who met these requirements were enrolled to the study, after registration with a third party before the start of MCFG treatment. Efficacy was evaluated by assessing the improvement in each of the following items: 1) clinical symptoms/findings possibly attributable to mycosis; 2) mycological findings; 3) imaging findings such as chest X-ray; 4) fungal serological tests. Efficacy was rated in 2 grades, namely effective and ineffective, based on an algorithm combining these indices (called AKOTT algorithm assessment). Results: Out of 180 registered patients, 116 patients (71 males, the mean age: 61.4 Â± 18.2) were evaluated for efficacy by the steering committee. The mean dosage and duration of dosing were 106.0 Â± 62.2 mg8901;per8901;day and 14.8 Â± 8.6 days, respectively. Common underlying diseases included perforation of the digestive tract, burns, stroke, and trauma. Clinically, 74 of 102 patients (72.5%) were rated as effective. By major diagnosis, the effective rates in patients with candidemia and pulmonary candidiasis were 77.8% and 84.6%, respectively. MCFG was effective not only against C. albicans but also against non-albicans Candida species. Adverse drug reactions occurred in 38 of 180 patients (21.1%), and the most commonly observed reaction was hepatic function disorder. There were no serious adverse drug reactions with a clear causal relationship to MCFG. Conclusion: MCFG demonstrated excellent clinical effects on systemic fungal infection in the areas of surgery, emergency, and intensive care medicine, indicating its usefulness as a new therapeutic drug.
Full conference title:
16th European Congress of Clinical Microbiology and Infectious Diseases
- ECCMID 16th (2006)