NCT00647907

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Vfend for the treatment of fungal infections

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2003

Shorter than P25 for phase_4

Geographic Reach
1 country

4 active sites

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

April 1, 2003

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
Last Updated

May 16, 2011

Status Verified

May 1, 2011

First QC Date

March 27, 2008

Last Update Submit

May 12, 2011

Conditions

CandidiasisCryptococcosisAspergillosis

Outcome Measures

Primary Outcomes (4)

  • Serological response (evaluated by approved diagnostic serological tests [cryptococcosis, coccidiomycosis, and histoplasmosis]) at Weeks 2, 8, 12, and end of therapy.

    Weeks 2, 8, 12, and end of therapy

  • Clinical response (evaluated based on change of attributable symptoms, signs, and/or bronchoscopic abnormalities present at baseline, judged by investigators, at Weeks 1, 2, 4, 8, 12, and end of therapy) at Weeks 1, 2, 4, 8, 12, and end of therapy.

    Weeks 1, 2, 4, 8, 12 and end of therapy

  • Radiological response (evaluated based on all radiological abnormalities [X-ray, computed tomography scan] attributed to fungal infection compared to baseline) at Weeks 2, 8, 12, and end of therapy.

    Weeks 2, 8, 12, and end of therapy

  • Mycological response (evaluated by the presences of fungal pathogen by relevant specimen [microscopy or histopathology]) at Weeks 2, 8, 12, and end of therapy.

    Weeks 2, 8, 12, and end of therapy

Secondary Outcomes (5)

  • Global response to treatment (incorporating clinical, mycological, radiological, and serological responses as applicable) at end of therapy/Week 16.

    End of therapy or Week 16

  • Change from baseline in laboratory parameters at Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up.

    Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up

  • Change from baseline in electrocardiogram at Week 1 and end of therapy.

    Week 1 and end of therapy

  • Incidence of adverse events at Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up.

    Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up

  • Visual safety testing at Weeks 1, 8, 12, end of therapy, Week 16, and follow-up.

    Weeks 1, 8, 12, end of therapy, Week 16, and follow-up

Study Arms (1)

A

EXPERIMENTAL
Drug: Voriconazole

Interventions

VoriconazoleDRUG

Oral or intravenous voriconazole. Oral tablets 400 mg twice daily loading dose on first day, followed by 200 mg twice daily taken at least 1 hour before or after a meal. Oral doses could be increased to a maximum of 300 mg twice daily if there was no clinical improvement after at least 3 days of treatment, no serious adverse events were reported, and clinical chemistry parameters were within the acceptable range for study entry. Intravenous treatment was initiated with a loading dose of 6 mg/kg twice daily for the first day followed by 4 mg/kg twice daily for at least 3 days (maximum infusion rate of 3 mg/kg/hr if administered by peripheral intravenous line). An intravenous loading dose was not required in patients who were restarted after oral treatment. Total duration of therapy (intravenous and oral) was 12 weeks.

A

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Systemic or invasive fungal infection
  • Infection caused by organism for which there is no current treatment or infection with evidence of failure and/or intolerance to treatment with approved antifungal agents

You may not qualify if:

  • Liver function test abnormalities
  • Renal disease
  • Fungal infections not considered to be invasive or systemic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pfizer Investigational Site

Kaohsiung City, Taiwan

Location

Pfizer Investigational Site

Taichung, 40705, Taiwan

Location

Pfizer Investigational Site

Taipei, 100, Taiwan

Location

Pfizer Investigational Site

Taipei, 114, Taiwan

Location

Related Links

MeSH Terms

Conditions

CandidiasisCryptococcosisAspergillosis

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 27, 2008

First Posted

April 1, 2008

Study Start

April 1, 2003

Study Completion

May 1, 2004

Last Updated

May 16, 2011

Record last verified: 2011-05

Locations

TW(4)