Strep Throat |
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Clinical Trial: A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients with Weakened Immune Systems
This study has been completed.
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Purpose
To determine the safety, toleration, and efficacy of fluconazole oral suspension in the treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Candidiasis, esophageal HIV Infections | Drug: Fluconazole | Phase III |
MedlinePlus related topics: AIDS; Candidiasis; Esophagus Disorders; Gastroenteritis
Study Type: Interventional
Study Design: Treatment, Safety Study
Official Title: An Open Multicenter Trial of Fluconazole Oral Suspension in the Treatment of Esophageal Candidiasis in Immunocompromised Patients
Expected Total Enrollment: 100
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.
Eligibility
Ages Eligible for Study: 13 Years - 70 Years, Genders Eligible for Study: Both
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.
Location Information
California
Los Angeles County - USC Med Ctr, Los Angeles, California, 90033, United States
Texas
Houston Veterans Administration Med Ctr, Houston, Texas, 77030, United States
More Information
Publications
Agresti MG, de Bernardis F, Mondello F, Bellocco R, Carosi GP, Caputo RM, Milazzo F, Chiodo F, Giannini V, Minoli L, et al. Clinical and mycological evaluation of fluconazole in the secondary prophylaxis of esophageal candidiasis in AIDS patients. An open, multicenter study. Eur J Epidemiol. 1994 Feb;10(1):17-22.
Record last reviewed: April 1996
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00002339
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Group A Streptococcal Infections (Cleveland Clinic)
- Strep throat (Google Health)

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