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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002038
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1996

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002038 on ClinicalTrials.gov Archive Site
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Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy
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.

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Interventional
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Primary Purpose: Treatment
  • Candidiasis
  • Mycoses
  • HIV Infections
Drug: Fluconazole
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002038
012C, 056-152
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Pfizer
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NIH AIDS Clinical Trials Information Service
June 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP