Olorofim Aspergillus Infection Study

Launched by F2G BIOTECH GMBH · Oct 19, 2021

Keywords

ClinConnect Summary

The Olorofim Aspergillus Infection Study is a clinical trial aimed at finding out how well a new treatment called olorofim works compared to a standard treatment known as AmBisome® for patients with invasive aspergillosis (IA), a serious fungal infection. The study is currently recruiting participants who are 18 years or older and weigh more than 30 kg. To be eligible, patients must have a confirmed or likely diagnosis of IA and should not have been on specific antifungal treatments for more than 28 days.

If you or a loved one participate in this trial, you will receive either olorofim or AmBisome® along with standard care for your condition. The trial is looking to see which treatment is more effective in helping patients recover from this infection. It's important to note that certain individuals, such as pregnant women or those with specific health conditions, may not be eligible to join the study. Participants will be monitored closely throughout the trial, and the goal is to find a better treatment option for this challenging infection.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male and female patients ages over 18 years and weighing more than 30 kg
• • 2. Patients with proven IA at any site or probable LRTD IA per EORTC/MSG 2019 criteria as adapted for this study and where the duration of specific therapy for this episode of IA has been ≤ 28 days. For purposes of this inclusion, the duration of specific therapy includes any mould-active therapy given for this episode of IA whether subsequently judged potentially effective or not.
• • 3. Patients requiring therapy with an antifungal agent other than a mould-active azole, and who have had ≤ 96 hours of potentially effective prior therapy. Potentially effective prior therapy includes any agent to which the infecting strain of Aspergillus is likely to be susceptible. There are no exclusions or limitations on such agents (eg, AmBisome® is permitted) other than their duration.
• • 4. AmBisome® is an appropriate therapy for the patient.
• Exclusion Criteria:
• • 1. Women who are pregnant or breastfeeding.
• • 2. Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug
• • 3. Patients with only chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
• • 4. Suspected mucormycosis (zygomycosis).
• • 5. Patients with a known active second fungal infection of any type, other than candidiasis that can be treated with fluconazole.
• • 6. The requirement for ongoing use of echinocandin as Candida prophylaxis.
• • 7. Microbiological findings (eg, bacteriological, virological) or other potential conditions that are temporally related and suggest a different aetiology for the clinical features.
• • 8. Human immunodeficiency virus (HIV) infection but not currently receiving antiretroviral therapy.
• • 9. Patients with a baseline prolongation of QT using Fridericia's Correction Formula (QTcF) ≥ 500 msec, or at high risk for QT/QTc prolongation.
• • 10. Evidence of hepatic dysfunction.