Invasive fungal infections due to Aspergillus spp.
Conditions
Brief summary
The primary efficacy endpoint is the ACM rate at Day 42 in the ITT population.
Detailed description
Investigator-assessed overall response (integrating clinical, radiological, and mycological response) at Day 14, Day 28, Day 42, Day 84, EOT, and FU., Data Review Committee-adjudicated assessment of overall response at Day 42, Day 84, and EOT., Serum GM at Day 14, Day 28, Day 42, Day 84, EOT, and FU., All cause mortality rate at Day 84., Survival time., Data Review Committee attribution of mortality to IA at Day 42 and Day 84, Diagnosis of a secondary fungal infection at any time through EOT., Quality of life as measured by the EQ-5D-5L at baseline, Day 14, and EOT.
Interventions
DRUGAmBisome Liposomal Amphotericin B 50mg Powder for Concentrate for Dispersion for Infusion
DRUGOlorofim
Sponsors
F2G Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the ACM rate at Day 42 in the ITT population. | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigator-assessed overall response (integrating clinical, radiological, and mycological response) at Day 14, Day 28, Day 42, Day 84, EOT, and FU., Data Review Committee-adjudicated assessment of overall response at Day 42, Day 84, and EOT., Serum GM at Day 14, Day 28, Day 42, Day 84, EOT, and FU., All cause mortality rate at Day 84., Survival time., Data Review Committee attribution of mortality to IA at Day 42 and Day 84, Diagnosis of a secondary fungal infection at any time through EOT., Quality of life as measured by the EQ-5D-5L at baseline, Day 14, and EOT. | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Spain
Outcome results
None listed