An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia
Completed · Phase 2
Conditions studied: Candidemia
In brief
This is a multicenter, open-label, non-comparative, single-arm study to evaluate the efficacy and safety of APX001 for the first-line treatment for candidemia including suspected or confirmed antifungal-resistant candidemia in non-neutropenic patients 18 yeas of age and older. Suspicion of antifungal-resistant candidemia is sufficient (documented resistance is not required for enrollment). The Study Drug Treatment Period of APX001 will be a maximum of 14 days. After completion of 14 days study drug therapy, if further antifungal treatment is indicated to complete treatment of candidemia in accordance with standard practice guidelines, fluconazole (unless susceptibility results warrant alternative antifungal therapy) may commence for up to a further 7 days. There will be a Follow up Period of 4 weeks (+4 days) after EOT. The total duration of participation in the study is up to approximately 7.5 weeks. This study will be conducted at approximately 20 sites in the United States and globally.
Key facts
- Study ID
- NCT03604705
- Run by
- Basilea Pharmaceutica
- People needed
- 21
- Starts
- 2018-10-03
- Expected to finish
- 2020-07-02
- Last updated by the study team
- 2025-09-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Alabama at Birmingham School of Medicine — Birmingham, Alabama, United States
- University of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States
- University of California, Davis — Davis, California, United States
- University of California-Davis Medical Center — Sacramento, California, United States
- Augusta University (Georgia Regents University) — Augusta, Georgia, United States
- University of Chicago — Chicago, Illinois, United States
- Washington University — St Louis, Missouri, United States
- Duke University Hospital Medical Center — Durham, North Carolina, United States
- University of Texas- Health Science Center and Medical School at Houston — Houston, Texas, United States
- Institut Jules Bordet,Service De Microbiologie — Brussels, Belgium
- Hopital Erasme — Brussels, Belgium
- Institut Jules Bordet — Brussels, Belgium
- Universite Libre de Bruxelles (ULB) - Hopital Erasme — Brussels, Belgium
- CHU de Charleroi - Hopital Civil Marie Curie — Lodelinsart, Belgium
- Mont-Godinne University Hospital — Yvoir, Belgium
- University Hospital Mont-Godinne — Yvoir, Belgium
- Klinik I fur Innere Medizin- Uniklinik Koln — Cologne, Germany
- University Hospital Heidelberg — Heidelberg, Germany
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - III. Medizinische Klinik Haematologie/Onkologie — Mainz, Germany
- Infectious Diseases Unit, Rambam Medical Center — Haifa, Israel
- Rambam Medical Center — Haifa, Israel
- Infectious Diseases Unit — Tel Aviv, Israel
- Sourasky Medical Center — Tel Aviv, Israel
- Infectious Diseases Unit,Sheba Medical Center — Tel Litwinsky, Israel
- Sheba Medical Center — Tel Litwinsky, Israel
Full record on ClinicalTrials.gov
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