An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/27/2019 |
| Start Date: | October 3, 2018 |
| End Date: | August 2020 |
| Contact: | Sara H Barbat |
| Email: | sbarbat@amplyx.com |
| Phone: | 858-876-6546 |
An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Non Neutropenic Patients With Candidemia, With or Without Invasive Candidiasis, Inclusive of Patients With Suspected Resistance to Standard of Care Antifungal Treatment
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 to 80 years of age
(inclusive).
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.
and safety of APX001 for the first-line treatment for candidemia including suspected or
confirmed antifungal-resistant candidemia in non-neutropenic patients 18 to 80 years of age
(inclusive).
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 Inclusion Criteria:
- Provision of written consent
- Ages 18-80 inclusive, 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
We found this trial at
8
sites
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University of Chicago One of the world's premier academic and research institutions, the University of...
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7000 Fannin Street
Houston, Texas 77030
Houston, Texas 77030
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