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

Last updated on February 22, 2019

FOR MORE INFORMATION
Study Location
Dr Layne Gentry
Houston, Texas, 77030 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Mycoses, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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.

NCT00002277
Pfizer
Completed
A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections

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[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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