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Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy

Last updated on February 22, 2019

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Study Location
Pfizer Central Research
Groton, Connecticut, 06340 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Candidiasis, Mycoses, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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Co-existing Condition:

A patient will be excluded if he/she has previously had an unacceptable adverse effect due
to fluconazole.

A patient will be excluded if he/she has previously had an unacceptable adverse effect due
to fluconazole.

AMENDED:

- 900207 Open only to unapproved indications and/or age ranges.

- Original design:

- Patients with clinically established serious or life-threatening systemic fungal
disease will be considered if conventional fungal therapy is not an acceptable
alternative. Unacceptability of conventional therapy is defined as:

- Failure of conventional therapy to control or eradicate infection after appropriate
trial(s) of generally accepted regimen(s).

- Serious and unacceptable untoward reaction(s) to conventional antifungal therapy.

- OR A major contraindication to the use of conventional antifungal therapy.

- The patient must be ineligible or have no access to other established fluconazole
investigational protocols. The final judgment of patient acceptability for inclusion
lies with the Pfizer Clinical Monitor.

NCT00002038
Pfizer
Completed
Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy

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[email protected]

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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