Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis
NCT00002010
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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.
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.
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Descriptive Information | |||
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Brief Title ICMJE | Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis | ||
Official Title ICMJE | Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis | ||
Brief 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. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Not Applicable | ||
Study Design ICMJE | Masking: None (Open Label) Primary Purpose: Treatment | ||
Condition ICMJE |
| ||
Intervention ICMJE | Drug: Fluconazole | ||
Study Arms ICMJE | Not Provided | ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Enrollment ICMJE | Not Provided | ||
Original Enrollment ICMJE | Not Provided | ||
Study Completion Date ICMJE | Not Provided | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria ICMJE | Inclusion Criteria Concurrent Medication: Allowed:
Concurrent Treatment: Allowed:
Patients must:
Prior Medication: Allowed:
Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded:
Concurrent Medication: Excluded:
Patients with the following are excluded:
| ||
Sex/Gender ICMJE |
| ||
Ages ICMJE | 13 Years and older (Child, Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00002010 | ||
Other Study ID Numbers ICMJE | 012P 056-170 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor ICMJE | Pfizer | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | NIH AIDS Clinical Trials Information Service | ||
Verification Date | February 1992 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |