Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Pathum Wan, Bangkok
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA).

Official Title

Phase III, Adjudicator-blinded, Randomised Study to Evaluate Efficacy and Safety of Treatment With Olorofim Versus Treatment With AmBisome® Followed by Standard of Care in Patients With Invasive Fungal Disease Caused by Aspergillus Species

Details

The mortality rate in immunosuppressed patients with IA is high even with effective modern antifungal drug treatment. Intrinsic and acquired resistance to azoles and amphotericin B, the two most effective classes of treatment, have been identified in Aspergillus species and are linked to this increased mortality. Currently marketed antifungal drugs have limitations including limited dosage forms, DDIs, and significant adverse reactions. For patients with IA who do not respond to or cannot tolerate a triazole therapy, treatment options are even more limited. Olorofim is an antifungal candidate with a novel mechanism of action offering activity against resistant organisms, differences in safety profile, along with oral dosing, predictable and reliable pharmacokinetic (PK) profile and limited potential for DDIs. The present study is designed to compare the efficacy, safety, and tolerability of olorofim with that of AmBisome® followed by guideline-based hierarchy standard of care (SOC) in patients with IA whose infection is either refractory to or unsuitable for azole therapy.

Keywords

Invasive Aspergillosis Invasive fungal disease (IFD) Aspergillus species Olorofim Non-azole antifungal Azole resistance Aspergillosis Amphotericin B Liposomal amphotericin B AmBisome® AmBisome

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Male and female patients ages over 18 years and weighing more than 40 kg
  2. Patients with proven IA at any site or probable LRTD IA per EORTC/MSG 2019 criteria as adapted for this study
  3. Patients requiring therapy with an antifungal agent other than a mould-active azole on the basis of IA refractory to mould-active azole therapy, proven resistance to the mould active azoles, breakthrough infection on mould-active triazole prophylaxis, or azole drug-drug interactions (or potential for drug-drug interactions).
  4. AmBisome® is an appropriate therapy for the patient.

You CAN'T join if...

  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 use of an 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.

Location

  • King Chulalongkorn Memorial Hospital accepting new patients
    Pathum Wan Bangkok 10330 Thailand

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
F2G Biotech GmbH
Links
Sign up for this study
ID
NCT05101187
Phase
Phase 3 Invasive Aspergillosis Research Study
Study Type
Interventional
Participants
Expecting 225 study participants
Last Updated