- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002277
A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections
June 23, 2005 updated by: Pfizer
Fluconazole Versus Amphotericin B: A Prospective, Randomized, Multicenter Study for Therapy of Fungal Infection
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Dr Layne Gentry
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Houston, Texas, United States, 77030
- Dr Temple Williams
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Houston, Texas, United States, 77030
- M D Anderson Cancer Ctr
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
December 1, 1993
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Bacterial Infections and Mycoses
- Infections
- Communicable Diseases
- Mycoses
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Amebicides
- 14-alpha Demethylase Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Fluconazole
- Amphotericin B
- Liposomal amphotericin B
Other Study ID Numbers
- 012N
- 056-173
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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