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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Amphotericin B

About this trial

This is an interventional treatment trial for Candidiasis, Esophageal focused on measuring AIDS-Related Opportunistic Infections, Esophagitis, Acquired Immunodeficiency Syndrome, Amphotericin B, Candidiasis, Oral

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Bristol - Myers Squibb Co

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002041

First Posted

November 2, 1999

Last Updated

October 1, 2007

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00002041

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Candidiasis, Esophageal, HIV Infections

Keywords

AIDS-Related Opportunistic Infections, Esophagitis, Acquired Immunodeficiency Syndrome, Amphotericin B, Candidiasis, Oral

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Amphotericin B

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Facility Information:

Facility Name

Bristol - Myers Squibb Co

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

085434000

Country

United States

Candidiasis, Esophageal, HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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