Coccidioidal MeningitisPhase 2NCT07385638
Olorofim in Early Coccidioidal Meningitis
A Phase 2 study testing olorofim in people with Coccidioidal Meningitis, run by Fariba Donovan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coccidioidal Meningitis
- What is being tested?
- olorofim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 15 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged ≥ 18 years and weighing ≥ 40 kg, able to understand and consent in English, who have been fully informed and:
- 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:
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- 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.
Who cannot join
- Patients who are unconscious.
- Patients who are pregnant or breastfeeding.
- 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.
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- 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.
- Patients with a concomitant medical condition that, in the opinion of the Investigator, may be an unacceptable additional risk to the patient should he/she participate in the study.
- Patients who have received prior treatment with olorofim/F901318.
- Treatment with any investigational drug within the 30 days prior to the first administration of study drug except for unblinded protocols (eg, open-label oncological regimen variations or biologic studies). Prior to enrolling patients who are on other open-label studies, it is the site's responsibility to ensure that the study criteria for that study allow for enrollment into this study.
- Patients receiving treatment limited to supportive care due to predicted short survival time.
- Patients with a baseline prolongation of QT using Fridericia's Correction Formula (QTcF) ≥ 500 msec, or at high risk for QT/QTc prolongation, eg,
- A family history of long QT syndrome
- Other known pro-arrhythmic conditions
- Risk factors for Torsade de Pointes (e.g., uncompensated heart failure, abnormal plasma potassium or magnesium levels that cannot be corrected, an unstable cardiac condition during the last 30 days).
- Evidence of hepatic dysfunction with any of the following abnormal laboratory parameters at screening:
- Total bilirubin ≥ 2 × upper limit of the normal range (ULN), OR
- Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 3 × ULN, OR
- Patients with known cirrhosis or chronic hepatic failure (regardless of ALT/AST/total bilirubin).
- Liver transplant recipients may be enrolled if their laboratory parameters do not meet the laboratory exclusions given above.
- Prohibited concomitant medications. Concomitant administration of inhibitors of human dihydro-orotate dehydrogenase (DHODH), teriflunomide, leflunomide, and systemic use of cannabis/cannabinoid preparations, including tetrahydrocannabinol (THC) and cannabidiol (CBD) are prohibited. There are currently no other absolutely prohibited concomitant medications for olorofim but there are medications with potentially significant drug-drug interactions (DDIs) with olorofim or SOC and the management of potential interactions should be considered before study enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Banner University Medical Center
Tucson, Arizona, 85719
Dakota Darby, 520-626-8000, dakotadarby@arizona.edu
About this study
Official title: 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.
- Conditions
- Coccidioidal Meningitis
- Being tested
- olorofim
- Keywords
- coccidioidomycosis
- Medical subject headings
- Coccidioidal Meningitis, Coccidioidomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olorofimDrug
Single group study - all participants will receive olorofim treatment
| Study group | Role | What they receive |
|---|---|---|
| olorofim | Experimental | Participants will receive treatment with olorofim Receives: Drug: olorofim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number of participants with ≥1 treatment-emergent adverse event
Counts and proportions of participants experiencing at least one adverse event after initiation of olorofim, regardless of causality. Adverse events will be coded and graded according to CTCAE v5.0.
Measured: First dose through end of treatment and 4-week follow-up
Secondary outcomes (9)
Efficacy: Investigator-assessed clinical response over 24 weeks
Proportion of participants with improvement or resolution of coccidioidal meningitis-related clinical signs and symptoms compared with baseline, as assessed by the investigator at protocol-specified visits.
Measured: Baseline through Week 24 (End of Treatment)
Efficacy: Change from baseline in Coccidioides serum complement fixation titers
Change in serum complement fixation titers from baseline, measured at scheduled study visits, as an indicator of mycological and disease response.
Measured: Baseline through Week 24
Efficacy: Radiological response assessed by imaging
Proportion of participants with stable or improved radiological findings related to coccidioidal meningitis on clinically indicated imaging studies compared with baseline.
Measured: Baseline through Week 24
Efficacy: Investigator-assessed overall treatment response
Proportion of participants with overall response based on integration of clinical status, radiological findings (if available), and mycological/serologic data, as assessed by the investigator using protocol-defined criteria.
Measured: Baseline through Week 24
Efficacy: All-cause mortality
Proportion of participants who die from any cause during treatment or follow-up.
Measured: Baseline through Week 24 and 4-week follow-up
Patient-reported Outcome: Change from baseline in Modified Zubrod Performance Score
Change from baseline in MZ-PS, a measure of functional performance status.
Measured: Baseline through Week 24
Patient-reported Outcome: Change from baseline in Valley Fever Patient-Reported Outcomes (VF-PRO) score
Change from baseline in VF-PRO questionnaire scores assessing symptom burden and quality of life related to coccidioidomycosis.
Measured: Baseline through Week 24
Patient-reported Outcome: Change from baseline in Clinical Global Impression-Severity (CGI-S) and Patient Global Impression-Severity (PGI-S)
Change from baseline in investigator-rated (CGI-S) and patient-reported (PGI-S) disease severity scores. (separate scales but reported similarly)
Measured: Baseline through Week 24
ECG Sub-Study: Change from baseline in QTcF interval
Change in QT interval corrected using Fridericia's formula (QTcF), measured using continuous Holter ECG monitoring and time-matched with plasma olorofim concentrations in a subset of participants.
Measured: Day 10-21 (single study day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Jun 2026
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coccidioidal MeningitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fariba Donovan
- Sponsor type
- University, hospital or other
- Collaborators
- F2G Biotech GmbH
- Responsible party
- Sponsor-investigator, Fariba Donovan, University of Arizona
- Investigators
- Fariba Donovan, MD, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385638
- Sponsor's protocol ID
- Study 00006853
- Status last verified
- Jul 2026
- First submitted
- 23 Jan 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including the analyzable dataset and associated metadata, will be shared with the study collaborator, F2G Ltd., for purposes of regulatory support, safety evaluation, and further analysis related to olorofim. Data shared will not include direct identifiers and will be coded prior to transfer.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Open-label Evaluation of Olorofim in Early Coccidioidal Meningitis
- ClinicalTrials.gov ID
- NCT07385638
- Acronym / sponsor ID
- Study 00006853
- Conditions
- Coccidioidal Meningitis
- Keywords
- coccidioidomycosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Fariba DonovanUniversity, hospital or other
- Collaborators
- F2G Biotech GmbH
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| olorofim | Experimental | Drug: olorofimParticipants will receive treatment with olorofim |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (22 listed)
- Patients who are unconscious.
- Patients who are pregnant or breastfeeding.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olorofimSingle group study - all participants will receive olorofim treatment | Drug | olorofim |
Primary outcome
Safety: Number of participants with ≥1 treatment-emergent adverse event
Time frame: First dose through end of treatment and 4-week follow-up
Counts and proportions of participants experiencing at least one adverse event after initiation of olorofim, regardless of causality. Adverse events will be coded and graded according to CTCAE v5.0.
9 secondary outcomes
Efficacy: Investigator-assessed clinical response over 24 weeks
Time frame: Baseline through Week 24 (End of Treatment)
Efficacy: Change from baseline in Coccidioides serum complement fixation titers
Time frame: Baseline through Week 24
Efficacy: Radiological response assessed by imaging
Time frame: Baseline through Week 24
Efficacy: Investigator-assessed overall treatment response
Time frame: Baseline through Week 24
Efficacy: All-cause mortality
Time frame: Baseline through Week 24 and 4-week follow-up
Patient-reported Outcome: Change from baseline in Modified Zubrod Performance Score
Time frame: Baseline through Week 24
Patient-reported Outcome: Change from baseline in Valley Fever Patient-Reported Outcomes (VF-PRO) score
Time frame: Baseline through Week 24
Patient-reported Outcome: Change from baseline in Clinical Global Impression-Severity (CGI-S) and Patient Global Impression-Severity (PGI-S)
Time frame: Baseline through Week 24
ECG Sub-Study: Change from baseline in QTcF interval
Time frame: Day 10-21 (single study day)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including the analyzable dataset and associated metadata, will be shared with the study collaborator, F2G Ltd., for purposes of regulatory support, safety evaluation, and further analysis related to olorofim. Data shared will not include direct identifiers and will be coded prior to transfer.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fariba Donovan, MD, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing olorofim in people with Coccidioidal Meningitis, run by Fariba Donovan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dakota Darby (5206268000, dakotadarby@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.