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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00002277

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mycoses HIV Infections	Drug: Fluconazole Drug: Amphotericin B	Phase 3

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Fluconazole Versus Amphotericin B: A Prospective, Randomized, Multicenter Study for Therapy of Fungal Infection

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.