Phase 2, Open-label Evaluation of Olorofim in Early Coccidioidal Meningitis
Fariba Donovan
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male and female patients aged ≥ 18 years and weighing ≥ 40 kg, able to understand and consent in English, who have been fully informed and: a) who have given voluntary written informed consent, or whose legally authorized representative(s) has been fully informed and has given voluntary written informed consent if applicable, and in compliance with local regulations OR 2. 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 underst…
Interventions
- Drugolorofim
Single group study - all participants will receive olorofim treatment
Location
- Banner University Medical CenterTucson, Arizona