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

This study has been completed.
Study NCT00002277.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

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Descriptive Information Fields
Brief Title  A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections
Official Title  Fluconazole Versus Amphotericin B: A Prospective, Randomized, Multicenter Study for Therapy of Fungal Infection
Brief Summary

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.

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Mycoses
HIV Infections
Intervention  Drug: Fluconazole
Drug: Amphotericin B
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date 
Completion Date
Eligibility 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.
Gender Both
Ages 13 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002277
Organization ID 012N
Secondary IDs †† 056-173
Study Sponsor  Pfizer
Collaborators ††
Investigators 
Information Provided By NIH AIDS Clinical Trials Information Service
Verification Date December 1993
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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