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A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections

This study has been completed.

Sponsored by: Pfizer
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002277
  Purpose

To compare the safety, tolerance and efficacy of fluconazole and amphotericin B as treatment for biopsy proven fungal infections in major organs, disseminated infection, suspected fungal infection and fungemia in adult neutropenic and non-neutropenic patients without AIDS, AIDS related complex (ARC), or extensive burns. HIV seropositive patients are allowed only if they also have a malignancy.


Condition Intervention Phase
Mycoses
HIV Infections
Drug: Fluconazole
Drug: Amphotericin B
Phase III

MedlinePlus related topics:   AIDS    Cancer    Fungal Infections    Molds   

ChemIDplus related topics:   Amphotericin B    Fluconazole   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Fluconazole Versus Amphotericin B: A Prospective, Randomized, Multicenter Study for Therapy of Fungal Infection
  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Immunostimulants under studies carried out under an IRB approved protocol.
  • Treatments of intercurrent non-fungal infection.
  • Allowed but requires monitoring during fluconazole therapy:
  • Barbiturates.
  • Phenytoin.
  • Oral hypoglycemics.
  • Coumarin-type anticoagulants.

Patients must have the following:

  • Diagnosis or presumption of fungal infection under defined conditions.
  • Written informed consent either from the patient or the patient's legal guardian.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Burns > 30 percent of the body.
  • Diagnosis of AIDS or AIDS related complex (ARC).
  • HIV positive unless they have a malignancy.
  • History of allergy to or intolerance of imidazoles or azoles.
  • Moderate to severe liver disease as defined by specific lab values.
  • Unlikely to survive more than 24 hours.
  • Evidence of previous amphotericin B sensitivity.

Concurrent Medication:

Excluded:

  • Concomitant antifungal agents other than the study drugs.
  • Immunostimulants, except for studies carried out under an IRB approved protocol.

Concurrent Treatment:

Excluded:

  • Lymphocyte replacements.

Patients with the following are excluded:

  • Defined disease conditions listed in Exclusion Co-Existing Conditions.
  • Unlikely to survive more than 24 hours.
  • Previous participation in this study; reentry for the same infection is not allowed.
  • Known to be unable to take amphotericin B due to acute toxicities.

Prior Medication:

Excluded:

  • Previous fluconazole therapy for this infection.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002277

Locations
United States, Texas
M D Anderson Cancer Ctr    
      Houston, Texas, United States, 77030
Dr Layne Gentry    
      Houston, Texas, United States, 77030
Dr Temple Williams    
      Houston, Texas, United States, 77030

Sponsors and Collaborators
Pfizer
  More Information


Study ID Numbers:   012N, 056-173
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002277
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Mycoses  
Neoplasms  
Neutropenia  
Fluconazole  
Amphotericin B  

Study placed in the following topic categories:
Abelcet
Fluconazole
Amphotericin B
Sexually Transmitted Diseases, Viral
Clotrimazole
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
Neutropenia
HIV Infections
Sexually Transmitted Diseases
AmBisome
Retroviridae Infections

Additional relevant MeSH terms:
Communicable Diseases
Anti-Infective Agents
RNA Virus Infections
Antiprotozoal Agents
Slow Virus Diseases
Immune System Diseases
Infection
Pharmacologic Actions
Anti-Bacterial Agents
Antiparasitic Agents
Therapeutic Uses
Antifungal Agents
Antibiotics, Antifungal
Lentivirus Infections
Amebicides

ClinicalTrials.gov processed this record on October 10, 2008




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