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Isavuconazole for treatment of invasive fungal diseases caused by more than one fungal species.
Marty, Francisco M; Cornely, Oliver A; Mullane, Kathleen M; Ostrosky-Zeichner, Luis; Maher, Rochelle M; Croos-Dabrera, Rodney; Lu, Qiaoyang; Lademacher, Christopher; Oren, Ilana; Schmitt-Hoffmann, Anne-Hortense; Giladi, Michael; Rahav, Galia; Perfect, John R.
Afiliação
  • Marty FM; Division of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA.
  • Cornely OA; Department of Internal Medicine, Clinical Trials Centre Cologne, ZKS Köln, and Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Cologne, Germany.
  • Mullane KM; Department of Medicine/Section of Infectious Diseases, University of Chicago, Chicago, IL, USA.
  • Ostrosky-Zeichner L; University of Texas Medical School at Houston and Memorial Hermann Texas Medical Center, University of Texas, Houston, TX, USA.
  • Maher RM; Astellas Pharma Global Development, Inc., Northbrook, IL, USA.
  • Croos-Dabrera R; Astellas Pharma Global Development, Inc., Northbrook, IL, USA.
  • Lu Q; Astellas Pharma Global Development, Inc., Northbrook, IL, USA.
  • Lademacher C; Astellas Pharma Global Development, Inc., Northbrook, IL, USA.
  • Oren I; Unit of Infectious Diseases, Rambam Health Care Campus, Haifa, Israel.
  • Schmitt-Hoffmann AH; Basilea Pharmaceutica International Ltd, Basel, Switzerland.
  • Giladi M; Infectious Disease Unit, Tel Aviv Sourasky Medical Center and The Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
  • Rahav G; Infectious Disease Unit, Sheba Medical Center, Tel Hashomer, and The Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
  • Perfect JR; Department of Medicine/Division of Infectious Diseases, Duke University, Durham, NC, USA.
Mycoses ; 61(7): 485-497, 2018 Jul.
Article em En | MEDLINE | ID: mdl-29611227
ABSTRACT
The optimal approach to treat invasive fungal disease (IFD) caused by more than one fungal species is unknown. We documented the efficacy and safety of isavuconazole for treatment of IFDs caused by more than one fungal species. VITAL was a single-arm, international, open-label study evaluating the efficacy and safety of isavuconazole (200 mg orally or intravenously every 8 hours for 48 hours, then once daily) for treatment of rare IFDs. The primary outcome was the overall response at Day 42; key secondary outcomes were overall responses at Day 84 and end of treatment (EOT), mortality at Days 42 and 84, and safety. This analysis includes patients with IFD caused by multiple fungal species. Fifteen patients were included in this analysis (including Aspergillus spp., n = 11; without Aspergillus spp., n = 4); median treatment duration was 97 days [range, 6-544] days). Overall treatment success was observed in 2/15 patients (13.3%) at Days 42 and 84, and 2/14 (14.3%) at EOT. All-cause mortality was 2/15 (13.3%) at Day 42 and 4/15 (26.7%) at Day 84. All patients had ≥1 treatment-emergent adverse event (TEAE); 12 patients (80.0%) had serious TEAEs; TEAEs led to discontinuation of isavuconazole in two patients (13.3%). Isavuconazole may be useful to treat some IFDs caused by multiple fungal species.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Piridinas / Triazóis / Coinfecção / Infecções Fúngicas Invasivas / Antifúngicos / Nitrilas Tipo de estudo: Clinical_trials Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2018 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Piridinas / Triazóis / Coinfecção / Infecções Fúngicas Invasivas / Antifúngicos / Nitrilas Tipo de estudo: Clinical_trials Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2018 Tipo de documento: Article