A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems

June 23, 2005 updated by: Pfizer

A Randomized Comparative Multicenter Trial of Fluconazole and Ketoconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients

To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Henderson Gen Hosp
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Good Samaritan Med Ctr
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hosp
    • California
      • Los Angeles, California, United States, 90033
        • Los Angeles County - USC Med Ctr
      • Rancho Mirage, California, United States, 92270
        • Eisenhower Med Ctr
      • San Francisco, California, United States, 94103
        • ViRx Inc
      • San Francisco, California, United States, 941430654
        • UCSF Hosp
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington Univ Med Ctr
    • Florida
      • Daytona Beach, Florida, United States, 32015
        • Regional Oncology Ctr
      • Fort Lauderdale, Florida, United States, 33308
        • Ctr for Special Immunology
      • Hollywood, Florida, United States, 33021
        • Mem Hosp Hollywood
      • Pensacola, Florida, United States, 325241151
        • Med Ctr Clinic
      • St Petersburg, Florida, United States, 33705
        • St Petersburg Med Clinics
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Georgia Baptist Med Ctr
      • Decatur, Georgia, United States, 30033
        • DeKalb Gen Hosp
      • Lawrenceville, Georgia, United States, 30245
        • Gwinnett Med Ctr
      • Riverdale, Georgia, United States, 30274
        • Atlanta Hosp
      • Riverdale, Georgia, United States, 30274
        • Clayton Gen Hosp
      • Roswell, Georgia, United States, 30076
        • Dr Winkler Weinberg
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Univ Hosp
      • Springfield, Massachusetts, United States, 01199
        • Baystate Med Ctr of Springfield
    • Michigan
      • Battle Creek, Michigan, United States, 49016
        • Leila Hosp and Health Care Ctr
      • Detroit, Michigan, United States, 48201
        • Harper Hosp
      • Grand Rapids, Michigan, United States, 49503
        • Butterworth Hosp
      • Holland, Michigan, United States, 49423
        • Holland Community Hosp
      • Traverse City, Michigan, United States, 49684
        • Munson Med Ctr
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Dr Eugene Speck
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Univ of New Mexico School of Medicine
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY / Health Sciences Ctr at Brooklyn
      • Buffalo, New York, United States, 14263
        • Roswell Park Memorial Institute
      • New York, New York, United States, 10021
        • Cornell Univ Med Ctr
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Bowman Gray School of Medicine / North Carolina Baptist Hosp
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Buckley Braffman Stern Med Associates
    • South Carolina
      • Spartanburg, South Carolina, United States, 29304
        • Wilson Brailsford Clinic
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Baroness Erlanger Hosp
      • Memphis, Tennessee, United States, 38163
        • Univ of Tennessee
    • Texas
      • Galveston, Texas, United States, 77550
        • Univ TX Galveston Med Branch
      • San Antonio, Texas, United States, 78284
        • Univ TX San Antonio Health Science Ctr
      • San Antonio, Texas, United States, 78284
        • Audie L Murphy Veterans Administration Hosp
    • Virginia
      • Annandale, Virginia, United States, 22203
        • Infectious Disease Physicians Inc
      • Richmond, Virginia, United States, 23249
        • McGuire Virginia Med Ctr
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Med Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Prior Medication:

Allowed:

  • Cyclosporin if levels can be monitored for proper cyclosporin dose adjustment.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Evidence of noncandidal systemic fungal infections.
  • Leukopenia (white blood cell count less than 1000/mm3), or expected to develop leukopenia during the study.
  • Other condition known to be associated with poor ketoconazole absorption, e.g., hypochlorhydria.
  • Leukemia requiring chemotherapy.
  • Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment.

Concurrent Medication:

Excluded:

  • Warfarin.
  • Immunostimulants.
  • Interferon.
  • Oral or topical antifungal agents.

Concurrent Treatment:

Excluded:

  • Lymphocyte replacement.

Patients with the following are excluded:

  • History of allergy to imidazoles.
  • Abnormalities which may preclude esophagoscopy or endoscopy before or during the study.
  • Inability to tolerate fluconazole or ketoconazole.
  • Inability or unwillingness to give written informed consent.
  • Life expectancy < 2 months.

Prior Medication:

Excluded:

  • Rifampin or ansamycin, pending clarification of drug interactions between these drugs and fluconazole.
  • Warfarin.

Patients must meet the CDC criteria for the diagnosis of AIDS or be otherwise immunocompromised (e.g., malignancy, renal transplant) and have a diagnosis of oral candidiasis and/or esophageal symptoms of dysphagia and/or odynophagia.

Illicit or illegal drug use.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

February 1, 1990

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012B
  • 056-150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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