Fluconazole Oral Suspension for Esophageal Candidiasis in Immunocompromised Patients
Fluconazole
Blood-Borne Infections+21
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Patients receive fluconazole oral suspension for a minimum of 3 weeks and maximum of 8 weeks. Patients are evaluated weekly, and treatment continues for 2 weeks after resolution of symptoms. Endoscopic exams and possibly biopsies are performed at baseline and at the end of treatment. Patients undergo follow-up at 2 weeks post-treatment.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 13 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria Patients must have: AIDS or other immunocompromising condition. Candidal esophagitis. Life expectancy of at least 2 months. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Evidence of non-candidal systemic fungal infection. Abnormalities that may preclude esophagoscopy or endoscopy. Unable to tolerate fluconazole. Unable to give informed consent. Enrollment in other experimental trials of approved or non-approved drugs or systemic compounds (unless approved by the Pfizer Clinical Monitor). Other condition that would make patient unsuitable for enrollment. Concurrent Medication: Excluded: Concomitant oral or topical antifungal agent. Other experimental medications. Patients with the following prior condition are excluded: History of allergy to imidazoles or azoles. Prior Medication: Excluded: Any oral or topical antifungal therapy within the past 3 days. Active use of illicit or illegal drugs.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Los Angeles County - USC Med Ctr
Los Angeles, United StatesOpen Los Angeles County - USC Med Ctr in Google MapsHouston Veterans Administration Med Ctr
Houston, United States