Detailed Information on Publication Record
2016
Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis
MARTY, Francisco M, Luis OSTROSKY-ZEICHNER, Oliver A CORNELY, Kathleen M MULLANE, John R PERFECT et. al.Basic information
Original name
Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis
Authors
MARTY, Francisco M (840 United States of America), Luis OSTROSKY-ZEICHNER (840 United States of America), Oliver A CORNELY (276 Germany), Kathleen M MULLANE (840 United States of America), John R PERFECT (840 United States of America), George R THOMPSON III (840 United States of America), George J ALANGADEN (840 United States of America), Janice M BROWN (840 United States of America), David N FREDRICKS (840 United States of America), Werner J HEINZ (276 Germany), Raoul HERBRECHT (250 France), Nikolai KLIMKO (643 Russian Federation), Galina KLYASOVA (643 Russian Federation), Johan A MAERTENS (56 Belgium), Sameer R MELINKERI (356 India), Ilana OREN (376 Israel), Peter G PAPPAS (840 United States of America), Zdeněk RÁČIL (203 Czech Republic, guarantor, belonging to the institution), Galia RAHAV (376 Israel), Rodrigo SANTOS (76 Brazil), Stefan SCHWARTZ (276 Germany), J Janne VEHRESCHILD (276 Germany), Jo-Anne H YOUNG (840 United States of America), Ploenchan CHETCHOTISAKD (764 Thailand), Sutep JARURATANASIRIKUL (764 Thailand), Souha S KANJ (422 Lebanon), Marc ENGELHARDT (756 Switzerland), Achim KAUFHOLD (756 Switzerland), Masanori ITO (840 United States of America), Misun LEE (840 United States of America), Carolyn SASSE (840 United States of America), Rochelle M MAHER (840 United States of America), Bernhardt ZEIHER (840 United States of America) and Maria J G T VEHRESCHILD (276 Germany)
Edition
Lancet Infectious Diseases, Oxford, Elsevier SCI LTD, 2016, 1473-3099
Other information
Language
English
Type of outcome
Článek v odborném periodiku
Field of Study
30300 3.3 Health sciences
Country of publisher
United Kingdom of Great Britain and Northern Ireland
Confidentiality degree
není předmětem státního či obchodního tajemství
Impact factor
Impact factor: 19.864
RIV identification code
RIV/00216224:14110/16:00089550
Organization unit
Faculty of Medicine
UT WoS
000378319600039
Keywords in English
LIPOSOMAL AMPHOTERICIN-B; MYCOSES STUDY-GROUP; FUNGAL-INFECTIONS; INVASIVE ASPERGILLOSIS; TRANSPLANT RECIPIENTS; EUROPEAN-ORGANIZATION; SALVAGE THERAPY; ZYGOMYCOSIS; POSACONAZOLE; VORICONAZOLE
Tags
Tags
International impact, Reviewed
Změněno: 4/8/2016 08:49, Ing. Mgr. Věra Pospíšilíková
Abstract
V originále
Background Mucormycosis is an uncommon invasive fungal disease with high mortality and few treatment options. Isavuconazole is a triazole active in vitro and in animal models against moulds of the order Mucorales. We assessed the effi cacy and safety of isavuconazole for treatment of mucormycosis and compared its effi cacy with amphotericin B in a matched case-control analysis. Methods In a single-arm open-label trial (VITAL study), adult patients (>= 18 years) with invasive fungal disease caused by rare fungi, including mucormycosis, were recruited from 34 centres worldwide. Patients were given isavuconazole 200 mg (as its intravenous or oral water-soluble prodrug, isavuconazonium sulfate) three times daily for six doses, followed by 200 mg/day until invasive fungal disease resolution, failure, or for 180 days or more. The primary endpoint was independent data review committee-determined overall response—ie, complete or partial response (treatment success) or stable or progressive disease (treatment failure)—according to prespecifi ed criteria. Mucormycosis cases treated with isavuconazole as primary treatment were matched with controls from the FungiScope Registry, recruited from 17 centres worldwide, who received primary amphotericin B-based treatment, and were analysed for day-42 allcause mortality. VITAL is registered with ClinicalTrials.gov, number NCT00634049. FungiScope is registered with ClinicalTrials.gov, number NCT01731353. Findings Within the VITAL study, from April 22, 2008, to June 21, 2013, 37 patients with mucormycosis received isavuconazole for a median of 84 days (IQR 19–179, range 2–882). By day 42, four patients (11%) had a partial response, 16 (43%) had stable invasive fungal disease, one (3%) had invasive fungal disease progression, three (8%) had missing assessments, and 13 (35%) had died. 35 patients (95%) had adverse events (28 [76%] serious). Day-42 crude all-cause mortality in seven (33%) of 21 primary-treatment isavuconazole cases was similar to 13 (39%) of 33 amphotericin B-treated matched controls (weighted all-cause mortality: 33% vs 41%; p=0·595). Interpretation Isavuconazole showed activity against mucormycosis with effi cacy similar to amphotericin B. Isavuconazole can be used for treatment of mucormycosis and is well tolerated.