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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002041
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : October 2, 2007
Sponsor:
Information provided by:
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Candidiasis, Esophageal HIV Infections Drug: Amphotericin B Not Applicable

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy





Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002041


Locations
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United States, New Jersey
Bristol - Myers Squibb Co
Princeton, New Jersey, United States, 085434000
Sponsors and Collaborators
Bristol-Myers Squibb
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ClinicalTrials.gov Identifier: NCT00002041    
Other Study ID Numbers: 001A
875-10
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: October 2, 2007
Last Verified: October 2007
Keywords provided by Bristol-Myers Squibb:
AIDS-Related Opportunistic Infections
Esophagitis
Acquired Immunodeficiency Syndrome
Amphotericin B
Candidiasis, Oral
Additional relevant MeSH terms:
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Candidiasis
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Mycoses
Amphotericin B
Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents