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- Title
Prospective pilot study of high-dose (10 mg/kg/day) liposomal amphotericin B (L-AMB) for the initial treatment of mucormycosis.
- Authors
Lanternier, F.; Poiree, S.; Elie, C.; Garcia-Hermoso, D.; Bakouboula, P.; Sitbon, K.; Herbrecht, R.; Wolff, M.; Ribaud, P.; Lortholary, O.; French Mycosis Study Group
- Abstract
<bold>Background: </bold>Mucormycosis incidence is increasing and is associated with a high rate of mortality. Although lipid-based formulations of amphotericin B are the recommended first-line treatment, only one prospective trial in a limited number of patients has been performed to evaluate this regimen.<bold>Methods: </bold>Patients with proven or probable mucormycosis were included between June 2007 and March 2011. Patients were scheduled to receive 10 mg/kg/day liposomal amphotericin B (L-AMB) monotherapy for 1 month and surgery was performed when appropriate. The primary outcome was response rate at week 4 or at the end of treatment (EOT) if before week 4, evaluated by an independent committee. ClinicalTrials.gov Identifier: NCT00467883.<bold>Results: </bold>Forty patients were enrolled. Response was analysed in 33 patients at week 4. Most patients had a haematological malignancy as their primary underlying disease (53%). Seventy-one percent of patients underwent therapeutic surgery. The response rate at week 4 or at EOT was 36%, with 18% partial responses and 18% complete responses. The response rate at week 12 was 45%, with 13% partial responses and 32% complete responses. Overall mortality was 38% at week 12 and 53% at week 24. Serum creatinine doubled in 16 (40%) patients and returned to normal levels within 12 weeks in 10/16 (63%).<bold>Conclusions: </bold>High-dose L-AMB for mucormycosis, in combination with surgery in 71% of cases, was associated with an overall response rate of 36% at week 4 and 45% at week 12 and creatinine level doubling in 40% of patients (transient in 63%). These results may serve as the basis for future clinical trials.
- Subjects
AMPHOTERICIN B; DRUG dosage; MUCORMYCOSIS; DRUG formularies; PILOT projects; LONGITUDINAL method; THERAPEUTICS; ANTIFUNGAL agents; CLINICAL trials; COMPARATIVE studies; DEBRIDEMENT; RESEARCH methodology; MEDICAL cooperation; MYCOSES; RESEARCH; EVALUATION research; TREATMENT effectiveness
- Publication
Journal of Antimicrobial Chemotherapy (JAC), 2015, Vol 70, Issue 11, p3116
- ISSN
0305-7453
- Publication type
journal article
- DOI
10.1093/jac/dkv236