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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002277 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections
Official Title ^ICMJE	Fluconazole Versus Amphotericin B: A Prospective, Randomized, Multicenter Study for Therapy of Fungal Infection
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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Mycoses HIV Infections
Intervention ^ICMJE	Drug: Fluconazole Drug: Amphotericin B
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	13 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002277
Responsible Party
Study ID Numbers ^ICMJE	012N, 056-173
Study Sponsor ^ICMJE	Pfizer
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	December 1993
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP