NCT00002041CompletedNot Applicable
Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients
Bristol-Myers Squibb1 site in 1 countryStarted: August 31, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Locations
- 1
Study Overview
Brief Summary
To determine the appropriate duration of amphotericin B therapy for Candida esophagitis. To compare the effectiveness of two different amphotericin B doses in the treatment of biopsy-proven Candida esophagitis. To determine if low-dose amphotericin B is less toxic than standard dose therapy during a limited treatment period. To evaluate pharmacokinetic and pharmacodynamic parameters of the two different dosing regimens.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Exclusion Criteria
- •Co-existing Condition:
- •Patients with histological or clinical (skin rash, cotton wool exudates, Candida endophthalmitis, etc.) evidence of disseminated candidiasis are excluded.
- •Concurrent Medication:
- •Systemic administration of amphotericin B for a proven or suspected systemic fungal infection.
- •Patients with the following are excluded:
- •Documented Candida fungemia.
- •Histological or clinical (skin rash, cotton wool exudates, Candida endophthalmitis, etc.) evidence of disseminated candidiasis.
- •Systemic administration of amphotericin B for a proven or suspected systemic fungal infection.
- •Patient refusal to enter study.
- •Patient must be an immunosuppressed host, with biopsy-proven Candida esophagitis.
- •Patients with polymicrobial esophagitis will be included as long as Candida esophagitis is documented by esophageal biopsy.
- •Informed consent must be signed and obtained.
Exclusion Criteria
- Not provided
Investigators
Study Sites (1)
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