Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis
Aspergillosis, Invasive Fungal Infection
About this trial
This is an interventional treatment trial for Aspergillosis focused on measuring Invasive fungal disease, BAL8557, Isavuconazole, ASP9766, Filamentous fungi, Phase III, Aspergillus species
Eligibility Criteria
Inclusion Criteria:
- Patients must have proven, probable or possible invasive fungal disease caused by Aspergillus species or other filamentous fungi
- Female patients must be non-lactating and at no risk for pregnancy
Exclusion Criteria:
- Patients with invasive fungal infections other than Aspergillus species or other filamentous fungi
- Evidence of hepatic dysfunction at Baseline or moderate to severe renal dysfunction
- Patients with chronic aspergillosis, or aspergilloma or allergic bronchopulmonary aspergillosis
- Patients who have received more than 4 days of systemic antifungal therapy other than fluconazole within the 7 days prior to the first administration of study medication
- Patients previously enrolled in a Phase III study with isavuconazole
- Patients with a body weight </= 40 kg
Sites / Locations
- University of Alabama
- University of California at San Francisco
- University of Chicago, Division of Infectious Diseases
- Indiana BMT
- Springfield Clinic LLP
- Infectious Disease of Indiana
- Brigham & Womens Hospital
- Upstate Infectious Diseases Association LLP
- Regional Infection Diseases Infusion Center Inc.
- University of Texas MD Anderson Cancer Center
- Hospital Italiano de Buenos Aires
- Instituto Medico Especializado Alexander Fleming
- Mater Medical Centre
- AZ ST Jan
- Institut Jules Bordet
- ULB Hospital Erasme
- Universitair Ziekenhuis Gent
- Universitaire Ziekenhuizen Leuven
- Felicio Rocho
- Santa Casa de Misericordia de Belo Horizonte
- Hospital das Clinicas da UFPR
- Hospital de Clinicas da FMUSP - Ribeirao Preto
- Hospital Universitario Clementino Fraga Filho
- The Ottawa Hospital - General Campus
- Hamilton Health Sciences - Henderson Site
- Hospital Dr. Hernan Henriquez Aravena
- 3rd Hospital, Peking University
- The 1st Hospital, Jilin University
- The Third Xiangya Hospital of Central South University
- West China Hospital of Sichuan University
- The Affiliated Union Hospital of Fujian Medical University
- The First Affiliated Hospital, Med. School, Zhejiang Uni.
- The First Affiliated Hospital of Nanjing Medical University
- The 1st Affiliated Hospital of Guangxi Medical University
- Huashan Hospital, Insitute of Antibiotics
- No.6 Renmin Hosp. of Shanghai City
- Chang Hai Hospital
- Wuhan Union Hospital
- Alexandria University Hospital
- National Cancer Institute
- Nasser Institute
- Hotel Dieu
- CHU de Nantes - Hôpital Hôtel Dieu
- Hôpital Hautepierre
- Hôpital de brabois adultes
- Universitaetsklinikum Aachen
- Charité Universitaetsmedizin Berlin- Campus Charité Mitte
- Universitaet Koeln
- Universitaetsklinik Leipzig
- Klinikum Schwabing
- Medizinische klinik und Polyklinik II
- Petz Aladar Megyei Oktato Korhaz
- Szegedi Tudomanyegyetem
- Apollo Hospitals
- Sterling Hospital
- Kasturba Medical College and Hospital
- Shirdi Sai Baba Cancer Hospital K. M. C. Hospital
- Tata Memorial Hopital, Department of Anesthesia
- Deenanath Mangeshkar Hospital & Research Centre
- Sahyadri Hospital
- Rambam Health Care Campus
- Hadassah Universtiy Hospital - Ein Kerem
- Rabin MC
- Chaim Sheba Medical Center
- Sourasky MC Ichilov Hospital Tel Aviv
- Unità Funzionale di Ematologia; Azienda Ospedaliera Universitaria Careggi
- Azienda Ospedaliera Ospedale Niguarda Ca' Granda
- Gachon University Gil Hospital
- Samsung Medical Center
- The Catholic University of Korea, St. Mary's Hospital
- Asan Medical Center
- Hospital Universitario Dr Jose Eleuterio Gonzalez
- Samodzielny Publiczny Centralny Szpital Kliniczny
- State Institution "Hematology Research Center" RAMS
- Republican Hospital named after V.A. Baranov
- Leningrad Regional Hospital
- St-Petersburg MA Postgraduate Education
- Songklanagarind Hospital
- Maharat Nakhon Ratchasima Hospital
- Srinagarind Hospital
- Maharaj Nakorn Chiang Mai Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Isavuconazole
Voriconazole
Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.