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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Amphotericin B; Fluconazole; Liposomal amphotericin B

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.