Phase 2
N=21
An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia
Candidemia
Bottom Line
View on ClinicalTrials.gov: NCT03604705 ↗Enrolled (actual)
21
Serious AEs
42.9%
Results posted
Aug 2021
Primary outcome: Primary: Treatment Success at End of Study Treatment (EOST) as Determined by the Data Review Committee (DRC) — 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- APX001 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Basilea Pharmaceutica
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Success at End of Study Treatment (EOST) as Determined by the Data Review Committee (DRC) |
16 | — |
| SECONDARY Time to First Negative Blood Culture |
2.4 | — |
| SECONDARY Percentage of Patients With Mycological Outcomes at End of Study Treatment (EOST), End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT) |
16; 15; 1; 0 | — |
| SECONDARY Percentage of Patients With Treatment Success at End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT) |
60.0; 55.0 | — |
| SECONDARY Overall Survival at Study Day 30 |
17 | — |
| SECONDARY Number of Patients With Treatment Emergent Adverse Events (TEAEs) |
20 | — |
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.
Eligibility Criteria
Key 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)
Key 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
Data sourced from ClinicalTrials.gov (NCT03604705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.