Phase 2, Open-label Evaluation of Olorofim in Early Coccidioidal Meningitis
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.
• 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
• 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:
‣ Postmenopausal for at least 1 year;
⁃ Post-hysterectomy and/or post-bilateral oophorectomy;
⁃ Of childbearing potential, with a negative urine or serum human chorionic gonadotropin pregnancy test at the screening visit and must be using one of listed below highly effective method of birth control throughout the course of the study period and up to and including 30 days after stopping study drug
• Established use of oral, injected, transdermal, intravaginal, or implanted hormonal methods of contraception associated with inhibition of ovulation
∙ Placement of an intrauterine device or intrauterine hormone-releasing system
∙ Male sterilization
∙ Bilateral tubal occlusion
∙ Sexual abstinence (reliable sexual abstinence is acceptable but periodic abstinence \[e.g., calendar, ovulation, symptom-thermal, or post-ovulation methods\] and withdrawal are not acceptable).
• 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.