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

Launched by PFIZER · Aug 30, 2001

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• • Exclusion Criteria
• 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.