NCT00143312

Brief Summary

To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants

Trial Health

93
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2005

Typical duration for phase_4

Geographic Reach
8 countries

17 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

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 1, 2009

Completed
Last Updated

October 6, 2009

Status Verified

September 1, 2009

Enrollment Period

3.2 years

First QC Date

August 31, 2005

Results QC Date

April 2, 2009

Last Update Submit

September 23, 2009

Conditions

Prophylaxis Of Invasive Fungal Infections

Keywords

Invasive Fungal Infection, Allogenic Stem Cell Transplant, prophylaxis, leukemia, voriconazole

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit

    Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 12-month follow up

    12 months

Secondary Outcomes (6)

  • Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit

    6 months

  • Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit

    150 days

  • Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI)

    12 months

  • Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)

    12 months

  • Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI)

    12 months

  • +1 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL
Drug: voriconazole

Interventions

voriconazoleDRUG

Voriconazole is given to patients at least 48 hours after chemotherapy

1

Eligibility Criteria

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

You may qualify if:

  • Patients with proven or probable IFI in previous 12 months receiving an allogenic stem cell transplant for any haematological disease

You may not qualify if:

  • Pregnant or lactating women
  • Severe disease other tham the underlying condition
  • Active, symptomatic uncontrolled Invasive Fungal Infection
  • Any evidence of active fungal disease as defined by MSG-EORTC criteria
  • Concomitant use of Voriconazole 36 hours before chemotherapy until 48 hours after chemotherapy
  • Other medical conditions, including HIV positive serology that would interfere with the evaluation of therapeutic response or safety of study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Pfizer Investigational Site

Leuven, 3000, Belgium

Location

Pfizer Investigational Site

Marseille, Cedex 09, 13273, France

Location

Pfizer Investigational Site

Créteil, 94010, France

Location

Pfizer Investigational Site

Nantes, 44035 cedex, France

Location

Pfizer Investigational Site

Pessac, 33600, France

Location

Pfizer Investigational Site

Strasbourg, 67098, France

Location

Pfizer Investigational Site

Cologne, 50937, Germany

Location

Pfizer Investigational Site

Mainz, 55101, Germany

Location

Pfizer Investigational Site

Würzburg, 97070, Germany

Location

Pfizer Investigational Site

Lisbon, Lisbon District, 1099-023, Portugal

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08025, Spain

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08036, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28006, Spain

Location

Pfizer Investigational Site

Stockholm, 141 86, Sweden

Location

Pfizer Investigational Site

Ch-4031 Basel, Switzerland

Location

Pfizer Investigational Site

London, W12 0NN, United Kingdom

Location

Pfizer Investigational Site

Manchester, M20 4BX, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Invasive Fungal InfectionsLeukemia

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.govCallCenter@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

February 1, 2005

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

October 6, 2009

Results First Posted

June 1, 2009

Record last verified: 2009-09

Locations

FR(5)GB(2)PT(1)ES(3)BE(1)DE(3)SE(1)CH(1)