Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis; Mycoses; HIV Infections
Intervention: Fluconazole (Drug)
Phase: N/A
Status: Completed
Sponsored by: Pfizer
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.
Clinical Details
Official title: Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy
Study design: Treatment, Dose Comparison
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Pfizer Central Research, Groton, Connecticut 06340, United States
Additional Information
Last updated: June 23, 2005
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