Clinical trial NCT00412893: Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis
Official title: A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Aspergillosis
Invasive Fungal Infection
Keywords: Invasive fungal disease
BAL8557
Isavuconazole
ASP9766
Filamentous fungi
Phase III
Aspergillus species
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Basilea Pharmaceutica International Ltd
First posted: 2006-12-19
Enrollment: 527
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.

Detailed description: Acute invasive fungal infections caused by aspergillus, zygomycetes and other filamentous fungi remain life threatening diseases. Early treatment with highly effective anti-fungals reduces mortality. This study investigates the efficacy and safety of isavuconazole in the treatment of invasive fungal diseases, caused by Aspergillus or other filamentous fungi.

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

Primary outcomes:
measure: All-cause Mortality Through Day 42
timeFrame: Through Day 42
Secondary outcomes:
measure: Percentage of Participants With an Overall Outcome of Success Evaluated by the Data Review Committee (DRC)
timeFrame: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
measure: All-cause Mortality Through Day 84
timeFrame: Through Day 84
measure: Percentage of Participants With an Overall Outcome of Success Evaluated by Investigator
timeFrame: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
measure: Percentage of Participants With a Clinical Response Assessed by the DRC
timeFrame: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
measure: Percentage of Participants With a Mycological Response Assessed by the DRC
timeFrame: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
measure: Percentage of Participants With a Radiological Response Assessed by the DRC
timeFrame: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
measure: Percentage of Participants With a Clinical Response Assessed by the Investigator
timeFrame: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
measure: Percentage of Participants With a Mycological Response Assessed by the Investigator
timeFrame: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
measure: Percentage of Participants With a Radiological Response Assessed by the Investigator
timeFrame: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
measure: Number of Participants With Adverse Events, Reported by System Organ Class
timeFrame: From the first study drug administration until 28 days after the last dose of study drug. The median duration of study drug administration was 45 days.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Chicago
country: United States
facility: University of Chicago, Division of Infectious Diseases
state: Illinois
city: Springfield
country: United States
facility: Indiana BMT
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic LLP
state: Illinois
city: Indianapolis
country: United States
facility: Infectious Disease of Indiana
state: Indiana
city: Boston
country: United States
facility: Brigham & Womens Hospital
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Albany
country: United States
facility: Upstate Infectious Diseases Association LLP
state: New York
city: Lima
country: United States
facility: Regional Infection Diseases Infusion Center Inc.
state: Ohio
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Capital Federal
country: Argentina
city: Capital Federal
country: Argentina
city: Ciudad Autonoma
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Ciudad Autonoma
country: Argentina
facility: Instituto Medico Especializado Alexander Fleming
city: Perth
country: Australia
city: South Brisbane
country: Australia
facility: Mater Medical Centre
city: Woolloongabba
country: Australia
city: Brugge
country: Belgium
facility: AZ ST Jan
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Bruxelles
country: Belgium
facility: ULB Hospital Erasme
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Belo Horizonte
country: Brazil
facility: Felicio Rocho
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte
city: Curitiba
country: Brazil
facility: Hospital das Clinicas da UFPR
city: Ribeirão Preto
country: Brazil
facility: Hospital de Clinicas da FMUSP - Ribeirao Preto
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitario Clementino Fraga Filho
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Henderson Site
city: Santiago
country: Chile
city: Temuco
country: Chile
facility: Hospital Dr. Hernan Henriquez Aravena
city: Valdivia
country: Chile
city: Beijing
country: China
facility: 3rd Hospital, Peking University
city: Changchun
country: China
facility: The 1st Hospital, Jilin University
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Fuzhou
country: China
facility: The Affiliated Union Hospital of Fujian Medical University
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Med. School, Zhejiang Uni.
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
city: Nanning
country: China
facility: The 1st Affiliated Hospital of Guangxi Medical University
city: Shanghai
country: China
facility: Huashan Hospital, Insitute of Antibiotics
city: Shanghai
country: China
facility: No.6 Renmin Hosp. of Shanghai City
city: Shanghai
country: China
facility: Chang Hai Hospital
city: Wuhan
country: China
facility: Wuhan Union Hospital
city: Alexandria
country: Egypt
facility: Alexandria University Hospital
city: Cairo
country: Egypt
facility: National Cancer Institute
city: Cairo
country: Egypt
facility: Nasser Institute
city: Dijon
country: France
city: Nantes Cedex 01
country: France
facility: Hotel Dieu
city: Nantes Cedex
country: France
facility: CHU de Nantes - Hôpital Hôtel Dieu
city: Strasbourg
country: France
facility: Hôpital Hautepierre
city: Vandoeuvre les Nancy
country: France
facility: Hôpital de brabois adultes
city: Aachen
country: Germany
facility: Universitaetsklinikum Aachen
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin- Campus Charité Mitte
city: Köln
country: Germany
facility: Universitaet Koeln
city: Leipzig
country: Germany
facility: Universitaetsklinik Leipzig
city: Luebeck
country: Germany
city: Muenchen
country: Germany
facility: Klinikum Schwabing
city: Würzburg
country: Germany
facility: Medizinische klinik und Polyklinik II
city: Budapest
country: Hungary
city: Györ
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem
city: Hyderabad
country: India
facility: Apollo Hospitals
state: Andh Prad
city: Ahmedabad
country: India
facility: Sterling Hospital
state: Gujarat
city: Mangalore
country: India
facility: Kasturba Medical College and Hospital
state: Karna
city: Manipal
country: India
facility: Shirdi Sai Baba Cancer Hospital K. M. C. Hospital
state: Karna
city: Mumbai
country: India
facility: Tata Memorial Hopital, Department of Anesthesia
state: Mahara
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital & Research Centre
state: Mahara
city: Pune
country: India
facility: Sahyadri Hospital
state: Mahara
city: Noida
country: India
state: Uttar Prad
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah Universtiy Hospital - Ein Kerem
city: Petah Tikva
country: Israel
facility: Rabin MC
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky MC Ichilov Hospital Tel Aviv
city: Firenze
country: Italy
facility: Unità Funzionale di Ematologia; Azienda Ospedaliera Universitaria Careggi
city: Milano
country: Italy
facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Kuala Lumpur
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Mexico
country: Mexico
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr Jose Eleuterio Gonzalez
city: Nijmegen
country: Netherlands
city: Palmerston North
country: New Zealand
city: Warszawa
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny
city: Moscow
country: Russian Federation
facility: State Institution "Hematology Research Center" RAMS
city: Petrozavodsk
country: Russian Federation
facility: Republican Hospital named after V.A. Baranov
city: St. Petersburg
country: Russian Federation
facility: Leningrad Regional Hospital
city: St. Petersburg
country: Russian Federation
facility: St-Petersburg MA Postgraduate Education
city: St. Petersburg
country: Russian Federation
city: Salamanca
country: Spain
city: Zurich
country: Switzerland
city: Hat Yai
country: Thailand
facility: Songklanagarind Hospital
city: Khon Kaen
country: Thailand
city: Muang
country: Thailand
facility: Maharat Nakhon Ratchasima Hospital
city: Muang
country: Thailand
facility: Srinagarind Hospital
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Songkla
country: Thailand
city: Istanbul
country: Turkey
Study officials:
affiliation: Astellas Pharma Global Development
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kovanda LL, Kolamunnage-Dona R, Neely M, Maertens J, Lee M, Hope WW. Pharmacodynamics of Isavuconazole for Invasive Mold Disease: Role of Galactomannan for Real-Time Monitoring of Therapeutic Response. Clin Infect Dis. 2017 Jun 1;64(11):1557-1563. doi: 10.1093/cid/cix198.
citation: Maertens JA, Raad II, Marr KA, Patterson TF, Kontoyiannis DP, Cornely OA, Bow EJ, Rahav G, Neofytos D, Aoun M, Baddley JW, Giladi M, Heinz WJ, Herbrecht R, Hope W, Karthaus M, Lee DG, Lortholary O, Morrison VA, Oren I, Selleslag D, Shoham S, Thompson GR 3rd, Lee M, Maher RM, Schmitt-Hoffmann AH, Zeiher B, Ullmann AJ. Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE): a phase 3, randomised-controlled, non-inferiority trial. Lancet. 2016 Feb 20;387(10020):760-9. doi: 10.1016/S0140-6736(15)01159-9. Epub 2015 Dec 10.