An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Patients with Candidemia with Suspected Resistance to Standard of Care Antifungal Treatment

Phase 1

• Conditions: 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: 20.0Level: LLTClassification code 10060573Term: CandidemiaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2017-003571-56-BE
• Lead Sponsor: Amplyx Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-04
• Study Completion: 2020-03-31
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 21

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

1. Neutropenia defined as absolute neutrophil count <500 cells/µL
2. Diagnosis of deep-seated Candida-related infections causing intraperitoneal Candidiasis, septic arthritis, osteomyelitis, endocarditis, myocarditis, meningitis, or central nervous system infection or site of infection that would require antifungal treatment to exceed maximal duration of study drug (14 days)
3. Hepatosplenic Candidiasis
4. Blood culture, or any other culture, positive for C. krusei
5. Received >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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified