Treatment of non-neutropenic subjects with candidemia – inclusive of those subjects with suspected or confirmed antifungal-resistant candidemia with or without invasive candidiasis MedDRA version: 20.0 Level: LLT Classification code 10060573 Term: Candidemia System Organ Class: 100000004862
Conditions
Interventions
Product Name: APX001
Product Code: APX001
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: APX001
CAS Number: 2091769-17-2
Current Sponsor code: APX001
Other descriptive
Sponsors
Amplyx Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female = 18 years of age 2. New diagnosis of candidemia based on a blood sample drawn within 96 hours of dosing with: a. Positive blood culture for Candida spp., including those Candida spp. with suspected (in the opinion of the Investigator) or documented resistance to at least 1 SOC systemic antifungal agent or b. Positive result from a Sponsor-approved rapid diagnostic blood test for Candida spp. infection (a rapid diagnostic test may be used to begin eligibility assessments; however, a subsequent confirmatory blood culture is required prior to dosing of APX001) 3. Able to have pre-existing intravascular catheters removed and replaced (if necessary) 4. Females of childbearing potential must have a negative urine pregnancy test Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Neutropenia defined as absolute neutrophil count 2 days (>48 hours) equivalent of prior systemic antifungal treatment at approved doses to treat the current episode of candidemia (e.g., 2 consecutive doses of an echinocandin) Note: = 5 days (=120 hours) equivalent of prior antifungal treatment is permitted for patients with candidemia caused by Candida spp. with documented resistance to the specific prior antifungal administered.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy and safety of APX001 for the treatment of adult non-neutropenic patients with candidemia that may include patients with suspected or confirmed resistance to standard of care (SOC) antifungal treatment.;Secondary Objective: - Evaluate the time to first negative blood culture - Evaluate the percentage of patients with Mycological Outcomes at End of Study Drug Treatment (EOST), End of Antifungal Treatment (EOT), and 2 and 4 weeks after EOT - Evaluate the percentage of patients with Treatment Success at EOT, and 2 and 4 weeks after EOT - Evaluate overall survival at Study Day 30 - Evaluate safety parameters, including number of patients with treatment-emergent adverse events (TEAEs) - Evaluate pharmacokinetic (PK) parameters of APX001;Primary end point(s): The primary efficacy parameter is Treatment Success at EOST as determined by the Data Review Committee (DRC).;Timepoint(s) of evaluation of this end point: End of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to first negative blood culture - Percentage of patients with Mycological Outcomes at EOST, EOT, and 2 and 4 weeks after EOT - Percentage of patients with Treatment Success at EOT, and 2 and 4 weeks after EOT - Overall survival at Study Day 30 - Number of patients with TEAEs;Timepoint(s) of evaluation of this end point: - At End of Study Drug Treatment (EOST) - At End of Antifungal Treatment (EOT) - At Follow-up (2 Weeks and 4 Weeks After End of Antifungal Treatment) | — |
Countries
Belgium, Germany, Israel, Spain, United States
Contacts
Public ContactShanshan Cui
Medpace
Outcome results
None listed