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”

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.

Intervention(s) in this Clinical Trial

• Drug: Fluconazole
• Drug: Amphotericin B

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002277

Study ID Number: 012N

ClinicalTrials.gov Identifier: NCT00002277

Health Authority: United States: Food and Drug Administration