Olorofim in Early Coccidioidal Meningitis

Conditions

• Coccidioidal Meningitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• olorofim — DRUG
  Single group study - all participants will receive olorofim treatment

Study Details

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.

Key Dates

Start date

Mar 15, 2026

Status verified

Jan 2026

Primary completion

Mar 15, 2027

Completion

Jun 15, 2027

Study Design

Enrollment

12 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: olorofim
  Participants will receive treatment with olorofim

Primary Outcome Measure

Safety: Number of participants with ≥1 treatment-emergent adverse event [ Time Frame: First dose through end of treatment and 4-week follow-up ]

Central Contacts

• Jose Elizondo
  5206210316
  [email protected]

Locations (1)

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