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

Official Title: “Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy”

The primary purpose of this protocol is to provide fluconazole for the treatment of individual patients who require therapy for serious or life-threatening systemic fungal infection, who have failed on conventional antifungal therapy or have had unacceptable reactions to conventional antifungal therapy, and who are ineligible for other established fluconazole clinical trial protocols.

Intervention(s) in this Clinical Trial

• Drug: Fluconazole

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002038

Study ID Number: 012C

ClinicalTrials.gov Identifier: NCT00002038

Health Authority: United States: Food and Drug Administration