Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
2 other identifiers
interventional
N/A
1 country
18
Brief Summary
To evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets for the treatment of esophageal candidiasis in immunocompromised patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
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
April 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- Esophageal candidiasis.
- Histological evidence of Candida spp. at baseline with confirmation by positive mycological culture.
- HIV infection or other predisposing risk factor.
- Life expectancy of at least 2 months.
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Malignancies of the head or neck, if the treatment or disease will interfere with response assessment.
- Evidence of systemic fungal infection.
- Underlying clinical condition that would preclude study completion.
- Judged to be unreliable in regard to following physician's directives.
- Concurrent Medication:
- Excluded:
- Rifampin.
- Rifabutin.
- Phenobarbital.
- Phenytoin.
- Carbamazepine.
- Terfenadine.
- Astemizole.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Dr Eskild A Petersen
Tucson, Arizona, 85724, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
UCSD Med Ctr
San Diego, California, 92103, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
Emory Univ School of Medicine
Atlanta, Georgia, 30303, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 21205, United States
Wayne State Univ / Harper Hosp
Detroit, Michigan, 48201, United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108, United States
Infectious Diseases Association / Research Med Ctr
Kansas City, Missouri, 64132, United States
Erie County Med Ctr
Buffalo, New York, 14215, United States
Dr Douglas Dieterich
New York, New York, 10016, United States
Montefiore Med Ctr
The Bronx, New York, 10467, United States
Univ of North Carolina
Chapel Hill, North Carolina, 27599, United States
Bowman Gray School of Medicine
Winston-Salem, North Carolina, 27157, United States
Univ Hosps of Cleveland
Cleveland, Ohio, 44106, United States
Austin Infectious Disease Consultants
Austin, Texas, 78705, United States
Houston Veterans Administration Med Ctr
Houston, Texas, 77030, United States
Related Publications (1)
Barbaro G, Barbarini G, Di Lorenzo G. Fluconazole compared with itraconazole in the treatment of esophageal candidiasis in AIDS patients: a double-blind, randomized, controlled clinical study. Scand J Infect Dis. 1995;27(6):613-7. doi: 10.3109/00365549509047076.
PMID: 8685642BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- DOUBLE
- 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: 1996-04