NCT00163111

Brief Summary

This is a study to investigate the safety and efficacy of voriconazole for the treatment of candidemia in critically ill non-neutropenic patients

Trial Health

100
On Track

Trial Health Score

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

Enrollment
412

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 1998

Longer than P75 for phase_3

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
Last Updated

April 26, 2011

Status Verified

April 1, 2011

First QC Date

September 9, 2005

Last Update Submit

April 25, 2011

Conditions

Candidiasis

Outcome Measures

Primary Outcomes (1)

  • Sustained clinical response for 12 weeks from end of treatment

Secondary Outcomes (1)

  • Time to negative blood cultures

Interventions

VFEND® I.V., OralDRUG
Conventional amphotericin BDRUG
Diflucan IV, oralDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with candidemia

You may not qualify if:

  • Neutropenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Candidiasis

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

September 1, 1998

Study Completion

May 1, 2003

Last Updated

April 26, 2011

Record last verified: 2011-04