An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia
Status:
Completed
Trial end date:
2020-07-02
Target enrollment:
Participant gender:
Summary
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.