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

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.