- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002010
Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis
June 23, 2005 updated by: Pfizer
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 Overview
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States, 85724
- Tucson Veterans Administration Med Ctr
-
-
California
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San Diego, California, United States, 92102
- HIV Research Group
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Texas
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San Antonio, Texas, United States, 78284
- Audie L Murphy Veterans Administration Hosp
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
February 1, 1992
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Meningitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Fluconazole
Other Study ID Numbers
- 012P
- 056-170
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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