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NCT Number: NCT03604705

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

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.

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Key information

Conditions

Candidemia Bacterial Infections and Mycoses Candidiasis Candidiasis, Invasive Fungemia Infections Inflammation Invasive Fungal Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hopital Erasme, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APX001

Drug

APX001

Primary outcomes

  1. Treatment Success at End of Study Treatment (EOST) as Determined by the Data Review Committee (DRC)

    Time frame: One to forty-two days

    Treatment Success is defined as meeting all of the following criteria:

    Two consecutive blood cultures negative for Candida spp. Alive at EOST No concomitant use of any other systemic antifungal therapies through end of study treatment

Secondary outcomes

  1. Time to First Negative Blood Culture

    Time frame: One to forty-nine days

    Time to first negative blood culture was defined as the number of days from first dose date of study drug to the date of first post-Baseline negative blood culture + 1. Patients without a negative blood culture at post-Baseline visits were censored at the last assessment date.

  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: End of study treatment (EOST), end of treatment (EOT), and 2 and 4 weeks after end of treatment (EOT)

  3. Percentage of Patients With Treatment Success at End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT)

    Time frame: 2 and 4 weeks after end of treatment (EOT)

  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

Sponsors and collaborators

Lead sponsor

Basilea Pharmaceutica

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2018
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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