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An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03604705
Recruitment Status : Active, not recruiting
First Posted : July 27, 2018
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Amplyx Pharmaceuticals

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Candidemia Drug: APX001 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: APX001 Treatment Drug: APX001
APX001


Outcome Measures
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Primary Outcome Measures :
  1. Treatment Success at end of study treatment (EOST) as determined by the Data Review Committee (DRC) [ Time Frame: One to forty-nine days ]

Secondary Outcome Measures :
  1. Time to first negative blood culture [ Time Frame: One to forty-nine days ]
  2. 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 ]
  3. 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 ]
  4. Overall survival at Study Day 30 [ Time Frame: Day 30 ]
  5. Number of patients with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: One to forty-nine days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Amplyx Pharmaceuticals
Investigators
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Study Director: Michael Hodges, MD Amplyx Pharmaceuticals
More Information
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Responsible Party: Amplyx Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03604705    
Other Study ID Numbers: APX001-201
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Candidemia
Fungemia
Sepsis
Infection
Candidiasis, Invasive
Candidiasis
 Mycoses
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes