Prospective pilot study of high-dose (10 mg/kg/day) liposomal amphotericin B (L-AMB) for the initial treatment of mucormycosis.
Details
Serval ID
serval:BIB_398DCBCD3BCB
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Prospective pilot study of high-dose (10 mg/kg/day) liposomal amphotericin B (L-AMB) for the initial treatment of mucormycosis.
Journal
The Journal of antimicrobial chemotherapy
Working group(s)
French Mycosis Study Group
Contributor(s)
Dromer F., Hoinard D., Chretien F., Jouvion G., Maizel J., Chouaki T., Hunault M., Bouchara J.P., Sirodot M., Gaillat J., Blanc X., Gobert Q., Leroy J., Legrand F., Navallou J., Grenouillet F., Million L., Blasco G., Malvy D., Accoceberry I., Ansart S., Moalic E., Reman O., Verdon R., Bonhomme J., Caillot D., Charles P., Chavanet P., Dalle F., Stahl J., Epaulard O., Thiebaut-Bertrand A., Cornet M., Guery B., Sendid B., Ferry T., Baudry T., Michallet M., Moutran M., Miailhes P., Bienvenu A., Faucher C., Gayet S., Ranque S., Jonquet O., Sterkers Y., Moreau P., Morio F., Roger P.M., Dellamonica P., Gari-Toussaint M., Veinstein A., Saulnier J., Kauffmann C., Arvieux C., Bernard M., Gandemer V., Gangneux J.P., Joly C., Pfister G., Veber B., Favennec L., Cazorla C., Raberin H., Letscher-Bru V., Sabou M., Alvarez M., Huynh A., Cassaing S., Giroux E., Dunand J., Naccache J.M., Gardin C., Freynet O., Brun S., Azoulay E., Lacroix C., Raffoux E., Joly V., Chochillon C., Charpentier J., Paugam A., Rivaud E., Cahen P., Novara A., Dannaoui E., Cordonnier C., Mekontso Dessap A., Botterel F., Bretagne S., Anguel N., Angoulvant A., Suarez F., Lacaille F., Oualha M., Bougnoux M.E., Combes A., Buffet P., Clair B., Dunand J., Maury E., Hennequin C., Tabone M.D., Wyplosz B., Merad M., Mihaila L.
ISSN
1460-2091 (Electronic)
ISSN-L
0305-7453
Publication state
Published
Issued date
11/2015
Peer-reviewed
Oui
Volume
70
Number
11
Pages
3116-3123
Language
english
Notes
Publication types: Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Abstract
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.
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.
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%).
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.
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.
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%).
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.
Keywords
Adolescent, Adult, Aged, Amphotericin B/administration & dosage, Antifungal Agents/administration & dosage, Child, Child, Preschool, Debridement, Female, Humans, Infant, Male, Middle Aged, Mucormycosis/drug therapy, Mucormycosis/surgery, Pilot Projects, Prospective Studies, Treatment Outcome, Young Adult
Pubmed
Web of science
Open Access
Yes
Create date
07/07/2023 11:04
Last modification date
18/07/2023 6:57
Usage data
