CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 48 enrolled
Drug / intervention
Voriconazoledrug
Likely dose
Voriconazole oral loading 400 mg twice daily on day 1, then maintenance 200 mg twice daily for 6-12 months; or IV loading 6 mg/kg twice daily on day 1, then maintenance 4 mg/kg twice dailyAI-extracted
Key inclusion· 4
  • Chronic bronchopulmonary aspergillosis confirmed by compatible chest imaging (CT scan) and/or endoscopic lesion with photo documentation
  • Complex aspergilloma that is non-primarily operable
  • Chronic necrotizing pulmonary aspergillosis
  • Tracheo-bronchial aspergillosis (obstructive or necrotizing/pseudo-membranous)
Key exclusion· 4
  • Risk factors for cardiac arrhythmia or symptomatic arrhythmia
  • Current treatment with medications known to prolong QT interval
  • QTc interval prolongation >450 msec in men or >470 msec in women
  • Simple aspergilloma with primary indication for surgical treatment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00159822
NCT00159822Phase 3Completed

Voriconazole For Primary Therapy Of Proven, Chronic Bronchopulmonary Aspergillosis, In Minimally Immunocompromised Or, Non-Immunocompromised Hosts

Pfizer·interventional·Posted Sep 12, 2005·Updated Jan 20, 2010

In Brief

A Phase 3 clinical trial evaluating Voriconazole for Aspergillosis. Completed, enrolled 48 participants across 18 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAspergillosis
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartJul 1, 2005
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 20.8 years ago

Interventions

Voriconazoledrug

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