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NCT07712484
A Phase II Randomized Study to Evaluate Measures for Endpoint Derivation in Patients With Progressive or Refractory Disseminated Coccidioidomycosis (DCM ) Treated With Olorofim Plus Baseline SOC or Placebo Plus Baseline SOC
Conditions: Coccidioidomycosis, Disseminated Fungal Infection, Coccidioides Infection, Coccidioides Immitis Infection, Coccidioides Posadasii Infection, Coccidioidomycosis Infection, San Joaquin Valley Fever, Valley Fever
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 50
Sponsor: F2G Ltd
Summary
The purpose of this study is to test measurement tools (questionnaire about symptoms and a questionnaire about quality of life) to assess usability in the assessment of treatment effectiveness for people with disseminated coccidioidomycosis (DCM).
Eligibility Criteria
Inclusion Criteria:
* Male and female patients, English- or Spanish-speaking, aged ≥18 years and weighing ≥40 kg.
* Patients with progressive or refractory disseminated coccidioidomycosis (DCM) involving extra-pulmonary sites with or without ongoing active disease in lungs.
* Standard of Care therapy for DCM to date has included 2 different triazoles (with or without a course of intravenous amphotericin B).
Exclusion Criteria:
* Patients who are unconscious.
* Women who are pregnant or breastfeeding.
* Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug.
* Patients with or planned placement of indwelling CNS devices.
* Patients receiving intrathecal amphotericin B at the time of study enrolment.
* Coccidioidomycosis limited to fibro-cavitary pulmonary disease.
* All bothersome DCM-related symptoms at study entry are due to irreversible damage (e.g., neurologic deficits due to stroke).
* Other than cutaneous fungal infections treated topically and Pneumocystis jirovecii infections, patients with a second fungal infection requiring systemic antifungal treatment or prophylaxis.
* Patients with microbiological findings or other potential conditions that are temporally related and suggest a different than study indication etiology for the clinical features.
* Patients living with Human immunodeficiency virus (HIV) unless for at least 6 months prior to enrollment:
1. Are receiving antiretroviral therapy AND
2. Have no evidence of current clinical progression resulting from HIV infection.
* Patients who have received prior treatment with olorofim/F901318.
* 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.
* Evidence of hepatic dysfunction.
Source: ClinicalTrials.gov (NCT07712484). StuddyBuddy aggregates publicly available trial information.