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

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

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.

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.