Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis
Launched by PFIZER · Aug 30, 2001
Trial Information
Current as of July 01, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Concurrent Medication:
- Allowed:
- • Immunosuppressive therapy including corticosteroids and/or cytotoxic agents.
- • Antiviral therapy (e.g., zidovudine (AZT)).
- • Prophylaxis for Pneumocystis carinii pneumonia (PCP).
- • Any exceptions to use of concomitant medications must be approved by Pfizer Central Research prior to study entry.
- Concurrent Treatment:
- Allowed:
- • Radiation therapy for mucocutaneous Kaposi's sarcoma.
- Patients must:
- • Be clinically judged to be in need of treatment for coccidioidal meningitis.
- • Have \> 1 week life expectancy.
- * Allowed:
- • Immunocompromised patients.
- • Patients with renal disease will have the dose of fluconazole adjusted and serum levels may be monitored.
- Prior Medication:
- Allowed:
- • Amphotericin B.
- • Ketoconazole.
- • Miconazole.
- • Exclusion Criteria
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- * Current antifungal infection that is responding to another agent. Findings of improvement include one of the following, while on other therapy (without subsequent relapse of the item):
- • CSF culture conversion from positive to negative.
- • OR
- • CSF antibody titer decrease of at least one dilution.
- • OR
- • Improvement in signs and symptoms of meningitis.
- • Have received more than minimal systemic antifungal therapy (see Patient Inclusion Criteria), unless they meet criteria for previous treatment failure or relapse. They must not have received this therapy since the time relapse or failure was documented, except for minimal antifungal therapy allowed in Patient Inclusion Criteria.
- • Immediately life-threatening coccidioidomycosis defined as infection of such a degree of clinical severity that the patient would be expected to die within 1 week, if untreated, based on clinical judgment.
- • Experienced a prior allergic reaction or major side effect from an imidazole or triazole compound.
- Concurrent Medication:
- Excluded:
- • Barbiturates.
- • Phenytoin.
- • Oral hypoglycemics.
- • Coumadin type anticoagulants.
- • Other systemic or intrathecal antifungal therapy.
- • Other experimental agents with exceptions noted in concomitant medications section.
- • Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research prior to study entry.
- Patients with the following are excluded:
- • Are responding or are improving on current antifungal therapy with another agent.
- • Have received more than minimal systemic antifungal therapy (see Patient Inclusion Criteria), unless they meet criteria for previous treatment failure or relapse. They must not have received this therapy since the time relapse or failure was documented, except for minimal antifungal therapy allowed in Patient Inclusion Criteria.
- • Immediately life-threatening coccidioidomycosis defined as infection of such a degree of clinical severity that the patient would be expected to die within 1 week, if untreated, based on clinical judgment.
- • Experienced a prior allergic reaction or major side effect from an imidazole or triazole compound.
About Pfizer
Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Antonio, Texas, United States
San Diego, California, United States
Tucson, Arizona, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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