An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia
Purpose
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.
Condition
- Candidemia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Provision of written consent - Adults ages 18 and above male or female - New diagnosis of candidemia - Able to have pre-existing intravascular catheters removed and replaced (as necessary)
Exclusion Criteria
- neutropenia - deep-seated Candida-related infections - hepatosplenic candidiasis - received more than 2 days of prior systemic antifungal treatment for current candidemia episode - severe hepatic impairment
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental APX001 Treatment |
|
More Details
- Status
- Completed
- Sponsor
- Pfizer