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

Basilea Pharmaceutica21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Candidemia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (29)

University of Alabama at Birmingham School of Medicine

Birmingham, Alabama, United States

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States

University of California, Davis

Davis, California, United States

University of California-Davis Medical Center

Sacramento, California, United States

Augusta University (Georgia Regents University)

Augusta, Georgia, United States

Outcomes

Primary Outcomes

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

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

Time frame: One to forty-two days

Secondary Outcomes

Time to First Negative Blood Culture

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.

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

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)

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