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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003435-11 | EudraCT Number |
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Business decision
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The purpose of the trial is to evaluate the safety and efficacy of a new antifungal with a novel mechanism of action in immunocompromised adults with invasive aspergillosis.
To compare the safety and efficacy of VL-2397 to standard first-line treatment for invasive aspergillosis in immunocompromised adults with acute leukemia or recipients of an allogeneic hematopoietic cell transplant (allo-HCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VL-2397 | Experimental | Investigational agent VL-2397 600 mg IV infusion administered every day for 28 days (4 weeks) followed by 2 weeks of standard treatment |
|
| Standard (First-Line) Treatment | Active Comparator | Investigator selected standard treatments of voriconazole, isavuconazole, or liposomal amphotericin B administered every day for 42 days (6 weeks) per product package insert |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Agent: VL-2397 | Drug | VL-2397 |
| |
| Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality (ACM) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ACM | 6 weeks | |
| Number of participants with adverse events | Number of participants with adverse events | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mammen P Mammen, MD, FIDSA | Vical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Hospital, Division of Infectious Diseases | Birmingham | Alabama | 35233 | United States | ||
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The Sponsor, safety monitoring board, and data review committee are masked.
| Drug |
Voriconazole, Isavuconazole, or Liposomal amphotericin B |
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| UC San Diego Moores Cancer Center |
| La Jolla |
| California |
| 92093 |
| United States |
| UC Davis Health, Dept. of Internal Medicine, Div. of Infectious Diseases | Sacramento | California | 95817 | United States |
| Christiana Care Health Services, Department of Medicine | Newark | Delaware | 19718 | United States |
| Medical College of Georgia at Augusta University | Augusta | Georgia | 30912 | United States |
| DMC Harper University Hospital | Detroit | Michigan | 48201 | United States |
| University of Minnesota, Department of Medicine | Minneapolis | Minnesota | 55455 | United States |
| Washington University School of Medicine, Division of Infectious Disease | St Louis | Missouri | 63110 | United States |
| The University of Texas Health Science Center, Department of Internal Medicine | Houston | Texas | 77030 | United States |
| Fred Hutchinson Cancer Research Center (FHCRC) | Seattle | Washington | 98109 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| University Hospital Antwerp (UZA), Department of Hematology | Edegem | Antwerp | B-2650 | Belgium |
| General Hospital Saint-Jan, Department of Hematology | Bruges | 8000 | Belgium |
| Jules Bordet Institute, Department of Infectious Disease | Brussels | 1000 | Belgium |
| University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology | Leuven | 3000 | Belgium |
| UCL Mont-Godinne University Hospitals, Department of Hematology | Yvoir | B-5530 | Belgium |
| Hamilton Health Sciences, Infectious Disease Research | Hamilton | Ontario | L8V 1C3 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2N2 | Canada |
| McGill University Health Centre (MUHC), Division of Infectios Diseases | Montreal | Quebec | H4A 3J1 | Canada |
| Grenoble University Hospital Center, Department of Hematology | Grenoble | 38700 | France |
| South Lyon Hospital Center | Pierre-Bénite | 69310 | France |
| Hautepierre Hospital | Strasbourg | 67200 | France |
| University Hospital Jena | Jena | 07740 | Germany |
| Hospital Neuperlach - Municipal Hospital Munich GmbH, Clinic of Hematology and Oncology | Munich | 81737 | Germany |
| Chonnam National University | Hwasun | 519-809 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Seoul National University Hospital | Seoul | 11 0-744 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| ID | Term |
|---|---|
| D055744 | Invasive Pulmonary Aspergillosis |
| ID | Term |
|---|---|
| D055732 | Pulmonary Aspergillosis |
| D001228 | Aspergillosis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000072742 | Invasive Fungal Infections |
| D008172 | Lung Diseases, Fungal |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C508735 | isavuconazole |
| C068538 | liposomal amphotericin B |
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