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

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Central Research
Groton, Connecticut, 06340 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Candidiasis, Mycoses, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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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.

NCT00002038
Pfizer
Completed
Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy

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Descriptive Information
Brief Title  ICMJE Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy
Official Title  ICMJE Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Candidiasis
  • Mycoses
  • HIV Infections
Intervention  ICMJE Drug: Fluconazole
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002038
Other Study ID Numbers  ICMJE 012C
056-152
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS AccountNIH AIDS Clinical Trials Information Service
Verification DateJune 1996

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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