A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections
NCT ID: NCT00002277
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Fluconazole
Amphotericin B
Eligibility Criteria
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Inclusion Criteria
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
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.
13 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Locations
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Dr Layne Gentry
Houston, Texas, United States
Dr Temple Williams
Houston, Texas, United States
M D Anderson Cancer Ctr
Houston, Texas, United States
Countries
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Other Identifiers
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056-173
Identifier Type: -
Identifier Source: secondary_id
012N
Identifier Type: -
Identifier Source: org_study_id