Official Title: “Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis”

The study is intended to examine the efficacy of fluconazole for the treatment of coccidioidal meningitis in patients with new onset of infection, relapse of previous infection, or failed previous therapy. Drug efficacy, safety and tolerance will be examined.

Study Type: Interventional

Study Design: Treatment, Open Label, Safety Study

Intervention(s) in this Clinical Trial

• Drug: Fluconazole

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002010

Study ID Number: 012P

ClinicalTrials.gov Identifier: NCT00002010

Health Authority: United States: Food and Drug Administration