A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
A Randomized Comparative Multicenter Trial of Fluconazole and Ketoconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients
2 other identifiers
interventional
N/A
2 countries
42
Brief Summary
To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
42 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:
- Prior Medication:
- Allowed:
- Cyclosporin if levels can be monitored for proper cyclosporin dose adjustment.
You may not qualify if:
- Co-existing Condition:
- Patients with the following are excluded:
- Evidence of noncandidal systemic fungal infections.
- Leukopenia (white blood cell count less than 1000/mm3), or expected to develop leukopenia during the study.
- Other condition known to be associated with poor ketoconazole absorption, e.g., hypochlorhydria.
- Leukemia requiring chemotherapy.
- Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment.
- Concurrent Medication:
- Excluded:
- Warfarin.
- Immunostimulants.
- Interferon.
- Oral or topical antifungal agents.
- Concurrent Treatment:
- Excluded:
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (42)
Good Samaritan Med Ctr
Phoenix, Arizona, 85006, United States
Arkansas Children's Hosp
Little Rock, Arkansas, 72202, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Eisenhower Med Ctr
Rancho Mirage, California, 92270, United States
ViRx Inc
San Francisco, California, 94103, United States
UCSF Hosp
San Francisco, California, 941430654, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
Regional Oncology Ctr
Daytona Beach, Florida, 32015, United States
Ctr for Special Immunology
Fort Lauderdale, Florida, 33308, United States
Mem Hosp Hollywood
Hollywood, Florida, 33021, United States
Med Ctr Clinic
Pensacola, Florida, 325241151, United States
St Petersburg Med Clinics
St. Petersburg, Florida, 33705, United States
Georgia Baptist Med Ctr
Atlanta, Georgia, 30338, United States
DeKalb Gen Hosp
Decatur, Georgia, 30033, United States
Gwinnett Med Ctr
Lawrenceville, Georgia, 30245, United States
Atlanta Hosp
Riverdale, Georgia, 30274, United States
Clayton Gen Hosp
Riverdale, Georgia, 30274, United States
Dr Winkler Weinberg
Roswell, Georgia, 30076, United States
Univ Hosp
Boston, Massachusetts, 02118, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199, United States
Leila Hosp and Health Care Ctr
Battle Creek, Michigan, 49016, United States
Harper Hosp
Detroit, Michigan, 48201, United States
Butterworth Hosp
Grand Rapids, Michigan, 49503, United States
Holland Community Hosp
Holland, Michigan, 49423, United States
Munson Med Ctr
Traverse City, Michigan, 49684, United States
Dr Eugene Speck
Las Vegas, Nevada, 89109, United States
Univ of New Mexico School of Medicine
Albuquerque, New Mexico, 87131, United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 11203, United States
Roswell Park Memorial Institute
Buffalo, New York, 14263, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Bowman Gray School of Medicine / North Carolina Baptist Hosp
Winston-Salem, North Carolina, 27103, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107, United States
Wilson Brailsford Clinic
Spartanburg, South Carolina, 29304, United States
Baroness Erlanger Hosp
Chattanooga, Tennessee, 37403, United States
Univ of Tennessee
Memphis, Tennessee, 38163, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284, United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203, United States
McGuire Virginia Med Ctr
Richmond, Virginia, 23249, United States
Virginia Mason Med Ctr
Seattle, Washington, 98101, United States
Henderson Gen Hosp
Hamilton, Ontario, Canada
Related Publications (1)
Laine L, Dretler RH, Conteas CN, Tuazon C, Koster FM, Sattler F, Squires K, Islam MZ. Fluconazole compared with ketoconazole for the treatment of Candida esophagitis in AIDS. A randomized trial. Ann Intern Med. 1992 Oct 15;117(8):655-60. doi: 10.7326/0003-4819-117-8-655.
PMID: 1308663BACKGROUND