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 range
13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.