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J Antimicrob Chemother. 2015 Nov;70(11):3116-23. doi: 10.1093/jac/dkv236. Epub 2015 Aug 27.

Prospective pilot study of high-dose (10 mg/kg/day) liposomal amphotericin B (L-AMB) for the initial treatment of mucormycosis.

Author information

1
Centre d'Infectiologie Necker Pasteur, Hôpital Universitaire Necker Enfants Malades, AP-HP, IHU Imagine, 149 rue de Sèvres, 75015 Paris, France Université Paris Descartes, Sorbonne Paris-Cité, Paris, France.
2
Service de Radiologie, Hôpital Universitaire Necker Enfants Malades, AP-HP, 149 rue de Sèvres, 75015 Paris, France.
3
Unité de Recherche Clinique/Centre d'Investigation Clinique, Hôpital Universitaire Necker Enfants Malades, AP-HP, 149 rue de Sèvres, 75015 Paris, France.
4
Institut Pasteur, Centre National de Référence Mycoses Invasives et Antifongiques, Paris, France Institut Pasteur, Unité de Mycologie Moléculaire, CNRS URA3012, Paris, France.
5
Service d'Onco-Hématologie, Hôpital d'Hautepierre, Strasbourg, France.
6
Service de Réanimation Médicale et des Maladies Infectieuses, Hôpital Bichat-Claude Bernard, Paris, France.
7
Université Paris Diderot, Sorbonne Paris-Cité, Service d'Hématologie-Greffe de Moelle, AP-HP, Hôpital Saint-Louis, Paris, France.
8
Centre d'Infectiologie Necker Pasteur, Hôpital Universitaire Necker Enfants Malades, AP-HP, IHU Imagine, 149 rue de Sèvres, 75015 Paris, France Université Paris Descartes, Sorbonne Paris-Cité, Paris, France Institut Pasteur, Centre National de Référence Mycoses Invasives et Antifongiques, Paris, France Institut Pasteur, Unité de Mycologie Moléculaire, CNRS URA3012, Paris, France olivier.lortholary@aphp.fr.

Abstract

BACKGROUND:

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.

METHODS:

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.

RESULTS:

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%).

CONCLUSIONS:

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.

PMID:
26316385
DOI:
10.1093/jac/dkv236
[Indexed for MEDLINE]

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