Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Amphotericin B; Liposomal amphotericin B

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:

Excluded:

• 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.