At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 9 enrolled
Drug / intervention
APX001drug
Likely dose
APX001 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Patients With Candidemia and/or Invasive Candidiasis Caused by Candida Auris
In Brief
A Phase 2 clinical trial evaluating APX001 for Candidemia and 2 related conditions. Completed, enrolled 9 participants across 2 sites.
Detailed Summary
This is a multicenter, open-label, single arm study to evaluate the efficacy and safety of APX001 for the treatment of candidemia and/or invasive candidiasis caused by C. auris in patients aged 18 years and over with limited antifungal treatment options.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCandidemia, Invasive Candidiases, Candida Infection
CountriesSouth Africa
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedNov 2019
Enrollment StartDec 2019
Primary CompletionNov 2020
Study CompletionDec 2020
TodayJul 2026
First PostedNov 1, 2019
Enrollment StartDec 13, 2019
Primary CompletionNov 30, 2020
Study CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 6.7 years ago
Interventions
APX001drug
Day 1: APX001 1000 mg IV BID over a 3-hour infusion Days 2-3: APX001 600 mg IV QD over a 3-hour infusion Days 4 - 42: APX001 600 mg IV QD over a 3-hour infusion or APX001 800 mg QD oral.