Universität zu Köln

Marty, Francisco M. ORCID: 0000-0002-3708-8734, Ostrosky-Zeichner, Luis, Cornely, Oliver A., Mullane, Kathleen M., Perfect, John R., Thompson, George R., III, Alangaden, George J., Brown, Janice M., Fredricks, David N., Heinz, Werner J., Herbrecht, Raoul ORCID: 0000-0002-9381-4876, Klimko, Nikolai, Klyasova, Galina, Maertens, Johan A., Melinkeri, Sameer R., Oren, Ilana, Pappas, Peter G., Racil, Zdenek, Rahav, Galia, Santos, Rodrigo, Schwartz, Stefan ORCID: 0000-0001-8833-5793, Vehreschild, J. Janne, Young, Jo-Anne H., Chetchotisakd, Ploenchan, Jaruratanasirikul, Sutep, Kanj, Souha S., Engelhardt, Marc, Kaufh, Achim, Ito, Masanori, Lee, Misun, Sasse, Carolyn, Maher, Rochelle M., Zeiher, Bernhardt and Vehreschild, Maria J. G. T. (2016). Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis. Lancet Infect. Dis., 16 (7). S. 828 - 838. OXFORD: ELSEVIER SCI LTD. ISSN 1474-4457

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Abstract

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). 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 efficacy similar to amphotericin B. Isavuconazole can be used for treatment of mucormycosis and is well tolerated.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Marty, Francisco M. UNSPECIFIED orcid.org/0000-0002-3708-8734 UNSPECIFIED Ostrosky-Zeichner, Luis UNSPECIFIED UNSPECIFIED UNSPECIFIED Cornely, Oliver A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mullane, Kathleen M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Perfect, John R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Thompson, George R., III UNSPECIFIED UNSPECIFIED UNSPECIFIED Alangaden, George J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Brown, Janice M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Fredricks, David N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Heinz, Werner J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Herbrecht, Raoul UNSPECIFIED orcid.org/0000-0002-9381-4876 UNSPECIFIED Klimko, Nikolai UNSPECIFIED UNSPECIFIED UNSPECIFIED Klyasova, Galina UNSPECIFIED UNSPECIFIED UNSPECIFIED Maertens, Johan A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Melinkeri, Sameer R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Oren, Ilana UNSPECIFIED UNSPECIFIED UNSPECIFIED Pappas, Peter G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Racil, Zdenek UNSPECIFIED UNSPECIFIED UNSPECIFIED Rahav, Galia UNSPECIFIED UNSPECIFIED UNSPECIFIED Santos, Rodrigo UNSPECIFIED UNSPECIFIED UNSPECIFIED Schwartz, Stefan UNSPECIFIED orcid.org/0000-0001-8833-5793 UNSPECIFIED Vehreschild, J. Janne UNSPECIFIED UNSPECIFIED UNSPECIFIED Young, Jo-Anne H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Chetchotisakd, Ploenchan UNSPECIFIED UNSPECIFIED UNSPECIFIED Jaruratanasirikul, Sutep UNSPECIFIED UNSPECIFIED UNSPECIFIED Kanj, Souha S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Engelhardt, Marc UNSPECIFIED UNSPECIFIED UNSPECIFIED Kaufh, Achim UNSPECIFIED UNSPECIFIED UNSPECIFIED Ito, Masanori UNSPECIFIED UNSPECIFIED UNSPECIFIED Lee, Misun UNSPECIFIED UNSPECIFIED UNSPECIFIED Sasse, Carolyn UNSPECIFIED UNSPECIFIED UNSPECIFIED Maher, Rochelle M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Zeiher, Bernhardt UNSPECIFIED UNSPECIFIED UNSPECIFIED Vehreschild, Maria J. G. T. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-271634
DOI:	10.1016/S1473-3099(16)00071-2
Journal or Publication Title:	Lancet Infect. Dis.
Volume:	16
Number:	7
Page Range:	S. 828 - 838
Date:	2016
Publisher:	ELSEVIER SCI LTD
Place of Publication:	OXFORD
ISSN:	1474-4457
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language LIPOSOMAL AMPHOTERICIN-B; MYCOSES STUDY-GROUP; FUNGAL-INFECTIONS; INVASIVE ASPERGILLOSIS; TRANSPLANT RECIPIENTS; EUROPEAN-ORGANIZATION; SALVAGE THERAPY; ZYGOMYCOSIS; POSACONAZOLE; VORICONAZOLE Multiple languages Infectious Diseases Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/27163