VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis (IA) in Adults
NCT03327727 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2019-02-27
Summary
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.
Conditions
- Invasive Aspergillosis
- Invasive Pulmonary Aspergillosis
Interventions
- DRUG
-
Investigational Agent: VL-2397
VL-2397
- DRUG
-
Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B
Voriconazole, Isavuconazole, or Liposomal amphotericin B
Sponsors & Collaborators
-
Vical
lead INDUSTRY
Principal Investigators
-
Mammen P Mammen, MD, FIDSA · Vical
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-20
- Primary Completion
- 2019-01-14
- Completion
- 2019-01-14
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Canada
- France
- Germany
- South Korea
Study Locations
More Related Trials
-
Micafungin Salvage Mono-therapy in Invasive Aspergillosis
NCT00376337 ·Status: TERMINATED ·Phase: PHASE2
-
Voriconazole vs. Amphotericin B in the Treatment of Invasive Aspergillosis
NCT00001646 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized Controlled Trial to Compare the Clinical Outcomes With Six Months of Therapy With Oral Itraconazole Versus Oral Voriconazole for Management of Treatment naïve Subjects With Chronic Pulmonary Aspergillosis
NCT04824417 ·Status: COMPLETED ·Phase: PHASE3
-
Isavuconazole for the Prevention of COVID-19-associated Pulmonary Aspergillosis
NCT04707703 ·Status: TERMINATED ·Phase: PHASE3
-
A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children
NCT00836875 ·Status: TERMINATED ·Phase: PHASE3
-
A Study to Evaluate the Effectiveness of Voriconazole + Micafungin Versus Voriconazole Alone for Invasive Aspergillosis
NCT00423163 ·Status: WITHDRAWN ·Phase: PHASE4
-
Voriconazole and Caspofungin Acetate in Treating Invasive Fungal Infections in Patients With Weakened Immune Systems
NCT00238355 ·Status: TERMINATED ·Phase: PHASE2
-
Early Diagnosis of Aspergillosis in Patients at High Risk of Fungal Infection Caused by Treatment for Hematologic Cancer or Other Disease
NCT00462657 ·Status: UNKNOWN ·Phase: NA
-
Voriconazole For Chronic Bronchopulmonary Aspergillosis
NCT00159822 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Effects of Fluconazole and Itraconazole CYP3A-Mediated Inhibition on the Pharmacokinetics, Safety, and Tolerability of MLN4924 in Participants With Advanced Solid Tumors
NCT02122770 ·Status: COMPLETED ·Phase: PHASE1
-
Isavuconazole in Preventing Invasive Fungal Infections in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome and Neutropenia
NCT03019939 ·Status: COMPLETED ·Phase: PHASE2
-
Voriconazole With or Without Interferon Gamma in Treating Patients With Aspergillosis or Other Fungal Infections
NCT00059878 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 1 Three Part SAD, MAD & Cross-Over Study of ZP-059 in Healthy and Asthmatic Subjects
NCT04229303 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy of Intrabronchial Voriconazole Instillation for Inoperable Pulmonary Aspergilloma
NCT03799809 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC)
NCT00750737 ·Status: COMPLETED ·Phase: PHASE3
-
Voriconazole Compared With Itraconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
NCT00079222 ·Status: COMPLETED ·Phase: NA
-
A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants
NCT03816176 ·Status: COMPLETED ·Phase: PHASE2
-
Concentrations of Voriconazole in Blood and BAL-fluid After Inhalation and Oral Administration
NCT02396225 ·Status: TERMINATED ·Phase: NA
-
Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants
NCT00143312 ·Status: COMPLETED ·Phase: PHASE4
-
Voriconazole to Prevent Systemic Fungal Infections in Children
NCT00005912 ·Status: COMPLETED ·Phase: PHASE1
-
Caspofungin Versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia
NCT01307579 ·Status: COMPLETED ·Phase: PHASE3
-
Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
NCT00413218 ·Status: COMPLETED ·Phase: PHASE3
-
An Open Label, Non-Comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections
NCT00001810 ·Status: COMPLETED ·Phase: PHASE3
-
Empirical Versus Preemptive Antifungal Therapy
NCT01288378 ·Status: COMPLETED ·Phase: PHASE3
-
Efflux Pump Mediated Azole Resistance in Candida Albicans
NCT03659162 ·Status: UNKNOWN