Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F16%3A00065326" target="_blank" >RIV/65269705:_____/16:00065326 - isvavai.cz</a>

Alternative codes found

RIV/00216224:14110/16:00089550

Result on the web

<a href="http://dx.doi.org/10.1016/S1473-3099(16)00071-2" target="_blank" >http://dx.doi.org/10.1016/S1473-3099(16)00071-2</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/S1473-3099(16)00071-2" target="_blank" >10.1016/S1473-3099(16)00071-2</a>

Result language

angličtina

Original language name

Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis

Original language description

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 efficacy and safety of isavuconazole for treatment of mucormycosis and compared its efficacy 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 prespecified 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 all-cause 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).

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FN - Epidemiology, infection diseases and clinical immunology

OECD FORD branch

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Project

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Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2016

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Lancet infectious diseases

ISSN

1473-3099

e-ISSN

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Volume of the periodical

16

Issue of the periodical within the volume

7

Country of publishing house

GB - UNITED KINGDOM

Number of pages

10

Pages from-to

828-837

UT code for WoS article

000378319600039

EID of the result in the Scopus database

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