A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B
Multi-Center Evaluation of Fluconazole (UK-49,858) as Treatment for Acute Cryptococcal Meningitis in Patients Who Have Failed to Respond or Have Experienced Unacceptable Toxicity During Treatment With Amphotericin B
2 other identifiers
interventional
N/A
1 country
14
Brief Summary
To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in patients who have had an unsatisfactory response to or have experienced unacceptable toxicity with amphotericin B.
Trial Health
Trial Health Score
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14 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
February 1, 1990
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Immunosuppressant therapy.
- Antiviral therapy such as zidovudine.
- Prophylaxis for Pneumocystis carinii pneumonia.
- Aerosolized pentamidine.
- Concurrent Treatment:
- Allowed:
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
- Not previously treated for acute cryptococcal meningitis and not eligible for Pfizer Central Research, protocol #159.
- Patients must have a baseline cerebrospinal fluid (CSF) culture-positive for Cryptococcus neoformans.
- Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.
- Each individual patient must be approved by Pfizer Central Research prior to study entry.
- Prior Medication:
- Allowed:
- +4 more criteria
You may not qualify if:
- Co-existing Condition:
- Patients with the following are excluded:
- Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
- History of allergy to or intolerance of imidazoles or azoles.
- Moderate or severe liver disease.
- Concurrent Treatment:
- Excluded:
- Lymphocyte replacement.
- Patients with the following are excluded:
- Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
- History of allergy to or intolerance of imidazoles or azoles.
- Moderate or severe liver disease.
- Satisfactory response to amphotericin B and have received a total amphotericin B dose of 15 mg/kg or more since CSF culture documentation of the current episode of acute cryptococcal meningitis.
- Life expectancy of \< 2 weeks.
- Prior Medication:
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (14)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
Univ of South Florida
Tampa, Florida, 33612, United States
Emory Univ School of Medicine
Atlanta, Georgia, 30303, United States
Med College of Georgia
Augusta, Georgia, 30912, United States
Univ Hosp
Boston, Massachusetts, 02118, United States
Ann Arbor Veterans Administration Med Ctr
Ann Arbor, Michigan, 48105, United States
Washington Univ School of Medicine
St Louis, Missouri, 63108, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10025, United States
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, 10468, United States
Cincinnati Veterans Adm Med Ctr / Univ Hosp
Cincinnati, Ohio, 452670405, United States
United States Air Force Med Ctr
Lackland Air Force Base, Texas, 782365300, United States
Southwest Texas Methodist Hosp
San Antonio, Texas, 78229, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1990-02