Olorofim in Early Coccidioidal Meningitis (NCT07385638) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Olorofim in Early Coccidioidal Meningitis
United States12 participantsStarted 2026-03-15
Plain-language summary
This research study is being conducted to learn more about the use of olorofim in Coccidioidal (Cocci) meningitis, a rare but serious fungal infection that affects the brain and spinal cord. The study is exploratory, meaning that early information is being gathered to better understand the effectiveness of olorofim in coccidioidal meningitis in its early stages. The study plans to enroll approximately 10 to 12 participants who have been recently diagnosed-within the last 4 to 8 weeks-and who do not have a ventriculoperitoneal (VP) shunt, a medical device sometimes used to relieve pressure in the brain. Participants will be followed for approximately 6 months, during which health information will be collected to evaluate disease progression and response to treatment. Participants may have the opportunity to enroll in the olorofim Managed Access Program to continue treatment after completion of the study period.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male and female patients aged ≥ 18 years and weighing ≥ 40 kg, able to understand and consent in English, who have been fully informed and:
✓. b) who have given oral informed consent witnessed in writing by an independent person and in compliance with local regulations for patients who are unable to write and/or read but who fully understand the oral information given by the Investigator (or nominated representative).
✓. Ongoing coccidioidomycotic meningitis diagnosed within 8 weeks prior to enrolment.
✓. Ongoing symptoms due to coccidioidomycosis are such that the risk-benefit of treatment with an investigational agent with a hepatic signal requiring careful monitoring is judged favorable based on meeting criteria
✓. Female patients must be non-lactating and at no risk of pregnancy for one of the following reasons:
✓. Male patients with female partners of childbearing potential must either totally abstain from sexual intercourse or use a highly effective means of contraception throughout study participation and agree to continue its use for 30 days after stopping study drug and may not donate semen during this time.
Exclusion criteria
What they're measuring
1
Safety: Number of participants with ≥1 treatment-emergent adverse event
Timeframe: First dose through end of treatment and 4-week follow-up
✕. Known history of allergy, hypersensitivity, or any serious reaction to any component of the olorofim.
✕. Patients with or planned placement of indwelling CNS hardware (e.g. reservoirs, shunts, ventriculostomies, or external drainage tubes).
✕. Patients with a second fungal infection requiring systemic antifungal treatment or prophylaxis, other than Pneumocystis jirovecii infections and cutaneous fungal infections treated topically.
✕. Patients with microbiological findings (e.g., bacteriological, virological) or other potential conditions that are temporally related and suggest a different than study indication etiology.
✕. HIV infection but not currently receiving antiretroviral therapy. In cases where HIV infection is first diagnosed at the same time as the invasive fungal infection, if antiretroviral therapy is commenced at the time of enrollment, then such patients are eligible for enrolment
✕. Any known or suspected medical condition or social circumstance of the patient that may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy.