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