Clinical trial · Interventional
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
NCT00002277CI-TRIAL-00000068completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV Infections | — | UNRESOLVED | — |
| Mycoses | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amphotericin B | Drug | Amphotericin B | ALIAS |
| Fluconazole | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.