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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00002038

Collaborator

(none)

Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Candidiasis Mycoses HIV Infections	Drug: Fluconazole	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Exclusion Criteria

Co-existing Condition:

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.