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Voriconazole For Chronic Bronchopulmonary Aspergillosis

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NCT00159822

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Nantes, Cedex, 44093 France
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Aspergillosis
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.
Show details

- Patients with a chronic bronchopulmonary aspergillosis assessed by a compatible chest
imagery (CT scan) and/or an endoscopic lesion sourced by photo, would it be:

- Complex aspergilloma non primarily operable,

- Chronic necrotizing pulmonary aspergillosis,

- Tracheo-bronchial aspergillosis, obstructive or necrotizing/pseudo-membranous.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patient with risk factor(s) of cardiac arrhythmia, symptomatic arrhythmia, treated by
medication known to prolong QT interval, or prolongation of QTc interval > 450 msec in
men and > 470 msec in women.

- Simple aspergilloma with primary indication of surgical treatment.

NCT00159822
Pfizer
Completed
Voriconazole For Chronic Bronchopulmonary Aspergillosis

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Voriconazole For Chronic Bronchopulmonary Aspergillosis
Voriconazole For Primary Therapy Of Proven, Chronic Bronchopulmonary Aspergillosis, In Minimally Immunocompromised Or, Non-Immunocompromised Hosts
To evaluate the efficacy of voriconazole (VFend(R)) as first line treatment for proven chronic bronchopulmonary aspergillosis, in minimally immunocompromised or non-immunocompromised patients after 6 months of treatment i.e. chronic necrotizing pulmonary
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Aspergillosis
Drug: Voriconazole

Voriconazole oral : loading dose on day 1 : 400mg/12 hours; maintenance dose 200 mg /12 hours for 6 to 12 months depending on clinical response.

Alternatively, patients may start on Voriconazole, IV, for 7 days loading dose, 6mg/Kg/12 hours on day one and maintenance dose 4 mg/Kg/12 hours
Experimental: 1
Intervention: Drug: Voriconazole
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
December 2008
December 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with a chronic bronchopulmonary aspergillosis assessed by a compatible chest imagery (CT scan) and/or an endoscopic lesion sourced by photo, would it be:
  • Complex aspergilloma non primarily operable,
  • Chronic necrotizing pulmonary aspergillosis,
  • Tracheo-bronchial aspergillosis, obstructive or necrotizing/pseudo-membranous.

Exclusion Criteria:

  • Patient with risk factor(s) of cardiac arrhythmia, symptomatic arrhythmia, treated by medication known to prolong QT interval, or prolongation of QTc interval > 450 msec in men and > 470 msec in women.
  • Simple aspergilloma with primary indication of surgical treatment.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00159822
A1501061
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2010

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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