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

Primary Purpose

Candidiasis, Mycoses, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluconazole
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis focused on measuring Mycoses, Drugs, Investigational, Fluconazole

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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. 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.

Sites / Locations

  • Pfizer Central Research

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00002038
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Mycoses, HIV Infections
Keywords
Mycoses, Drugs, Investigational, Fluconazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fluconazole

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Pfizer Central Research
City
Groton
State/Province
Connecticut
ZIP/Postal Code
06340
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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