Olorofim Aspergillus Infection Study

Overview

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

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.

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 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Paschalis Vergidis, M.D.

Open for enrollment

Contact information:

Department of Medicine (DOM) Research Hub

(507) 266-1944

DOMRESEARCHHUB@mayo.edu

More information

Publications

Publications are currently not available