An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia
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|ClinicalTrials.gov Identifier: NCT03604705|
Recruitment Status : Active, not recruiting
First Posted : July 27, 2018
Last Update Posted : February 28, 2020
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 or disease||Intervention/treatment||Phase|
|Candidemia||Drug: APX001||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 3, 2018|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
|Experimental: APX001 Treatment||
- Treatment Success at end of study treatment (EOST) as determined by the Data Review Committee (DRC) [ Time Frame: One to forty-nine days ]
- Time to first negative blood culture [ Time Frame: One to forty-nine days ]
- 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) [ Time Frame: One to forty-nine days ]
- Percentage of patients with Treatment Success at end of treatment (EOT), and 2 and 4 weeks after end of treatment (EOT) [ Time Frame: One to forty-nine days ]
- Overall survival at Study Day 30 [ Time Frame: Day 30 ]
- Number of patients with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: One to forty-nine days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604705
|Study Director:||Michael Hodges, MD||Amplyx Pharmaceuticals|