Summary

for people ages 18-80 (full criteria)
at Davis, California and other locations
study started
estimated completion

Description

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 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.

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

Keywords

Candidemia APX001

Eligibility

For people ages 18-80

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

Locations

  • University of California, Davis accepting new patients
    Davis California 95616 United States
  • University of Texas- Health Science Center and Medical School at Houston accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amplyx Pharmaceuticals
Links
Sign up for this study
ID
NCT03604705
Phase
Phase 2
Study Type
Interventional
Last Updated