Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis (NCT00002010) | Clinical Trial Compass
CompletedNot Applicable
Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis
United States
Plain-language summary
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.
Who can participate
Age range13 Years
SexALL
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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 fa…