NCT00002038

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 1996

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

CandidiasisMycosesHIV Infections

Keywords

MycosesDrugs, InvestigationalFluconazole

Interventions

FluconazoleDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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:
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Central Research

Groton, Connecticut, 06340, United States

Location

MeSH Terms

Conditions

CandidiasisMycosesHIV Infections

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1996-06

Locations

US(1)