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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002277
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Mycoses

Keywords

Mycoses, Neoplasms, Neutropenia, Fluconazole, Amphotericin B

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.

Interventions

DRUGFluconazole
DRUGAmphotericin B

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026