VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis (IA) in Adults
NCT ID: NCT03327727
Last Updated: 2019-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2018-02-20
2019-01-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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VL-2397
Investigational agent VL-2397 600 mg IV infusion administered every day for 28 days (4 weeks) followed by 2 weeks of standard treatment
Investigational Agent: VL-2397
VL-2397
Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B
Voriconazole, Isavuconazole, or Liposomal amphotericin B
Standard (First-Line) Treatment
Investigator selected standard treatments of voriconazole, isavuconazole, or liposomal amphotericin B administered every day for 42 days (6 weeks) per product package insert
Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B
Voriconazole, Isavuconazole, or Liposomal amphotericin B
Interventions
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Investigational Agent: VL-2397
VL-2397
Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B
Voriconazole, Isavuconazole, or Liposomal amphotericin B
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* IA involving sites other than lungs and sinuses
* Graft failure, acute or extensive chronic GvHD
* Uncontrolled diabetes
18 Years
ALL
No
Sponsors
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Vical
INDUSTRY
Responsible Party
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Principal Investigators
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Mammen P Mammen, MD, FIDSA
Role: STUDY_DIRECTOR
Vical
Locations
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University of Alabama at Birmingham Hospital, Division of Infectious Diseases
Birmingham, Alabama, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
UC Davis Health, Dept. of Internal Medicine, Div. of Infectious Diseases
Sacramento, California, United States
Christiana Care Health Services, Department of Medicine
Newark, Delaware, United States
Medical College of Georgia at Augusta University
Augusta, Georgia, United States
DMC Harper University Hospital
Detroit, Michigan, United States
University of Minnesota, Department of Medicine
Minneapolis, Minnesota, United States
Washington University School of Medicine, Division of Infectious Disease
St Louis, Missouri, United States
The University of Texas Health Science Center, Department of Internal Medicine
Houston, Texas, United States
Fred Hutchinson Cancer Research Center (FHCRC)
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
University Hospital Antwerp (UZA), Department of Hematology
Edegem, Antwerp, Belgium
General Hospital Saint-Jan, Department of Hematology
Bruges, , Belgium
Jules Bordet Institute, Department of Infectious Disease
Brussels, , Belgium
University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology
Leuven, , Belgium
UCL Mont-Godinne University Hospitals, Department of Hematology
Yvoir, , Belgium
Hamilton Health Sciences, Infectious Disease Research
Hamilton, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
McGill University Health Centre (MUHC), Division of Infectios Diseases
Montreal, Quebec, Canada
Grenoble University Hospital Center, Department of Hematology
Grenoble, , France
South Lyon Hospital Center
Pierre-Bénite, , France
Hautepierre Hospital
Strasbourg, , France
University Hospital Jena
Jena, , Germany
Hospital Neuperlach - Municipal Hospital Munich GmbH, Clinic of Hematology and Oncology
Munich, , Germany
Chonnam National University
Hwasun, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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2017-003435-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VL2397-201
Identifier Type: -
Identifier Source: org_study_id
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