Comparison of Voriconazole and Amphotericin B in Treating Patients With Aspergillosis
- Conditions
- InfectionPulmonary Complications
- Registration Number
- NCT00003031
- Brief Summary
RATIONALE: Antifungal therapy with voriconazole or amphotericin B may be an effective treatment for aspergillosis. It is not yet known whether voriconazole is more effective than amphotericin B in treating patients with aspergillosis.
PURPOSE: Randomized phase III trial to compare the effectiveness of voriconazole with amphotericin B in treating patients with aspergillosis.
- Detailed Description
OBJECTIVES: I. Compare the efficacy, safety, and toleration of voriconazole versus amphotericin B (CAB) in the treatment of acute invasive aspergillosis in immunocompromised patients. II. Compare the efficacy, safety, and toleration of voriconazole versus CAB followed by other antifungal therapy in the treatment of acute invasive aspergillosis in immunocompromised patients. III. Compare survival in patients treated with voriconazole versus CAB with or without other antifungal therapy. IV. Investigate resource utilization in patients treated with voriconazole versus CAB with or without other antifungal therapy.
OUTLINE: This is an open label, randomized, multicenter study. Patients are stratified according to center, site of infection, underlying disease, and baseline neutrophil count. Patients are randomized to one of two treatment arms. Arm I: Patients receive voriconazole IV every 12 hours for 7-28 days and continue with oral voriconazole twice a day for a maximum total duration of 12 weeks of therapy. Arm II: Patients receive intravenous amphotericin B daily for at least 2 weeks; treatment continues for a maximum of 12 weeks. Patients discontinued from study drug treatment because of toxicity, intolerance or clinical failure may receive alternative (nonstudy) antifungal therapy. All patients are monitored for a total of 16 weeks.
PROJECTED ACCRUAL: A sufficient number of patients will be accrued so that 212 patients (106 per study arm) will be eligible for the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 212
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (74)
St. Vincent's Hospital
🇦🇺Sydney, New South Wales, Australia
King's College Hospital
🇬🇧London, England, United Kingdom
Hospital de Cruces
🇪🇸Barakaldo, Bilbao, Spain
Ospedale Maggiore Ca Granda
🇮🇹Milan, Italy
Hospital Del Mar
🇪🇸Barcelona, Spain
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
North Manchester Healthcare NHS Trust
🇬🇧Manchester, United Kingdom
Hospital General Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitasrio San Carlos
🇪🇸Madrid, Spain
University Hospital - Salamanca
🇪🇸Salamanca, Spain
Hospital Clinic y Provincial de Barcelona
🇪🇸Barcelona, Spain
Ospedale San Orsola
🇮🇹Bologna, Italy
Istituto Nazionale per la Ricerca sul Cancro
🇮🇹Genoa, Italy
University and I.R.C.C.S. Policlinico San Matteo
🇮🇹Pavia, Italy
Policlinico Monteluce
🇮🇹Perugia, Italy
Ospedale Civile Pescara
🇮🇹Pescara, Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
🇮🇹Rome, Italy
Centre Hospitalier de Luxembourg
🇱🇺Luxembourg, Luxembourg
Szent Laszlo Korhaz
ðŸ‡ðŸ‡ºBudapest, Hungary
Hopital Du Bocage
🇫🇷Dijon, France
Hartford Medical Group
🇺🇸Wethersfield, Connecticut, United States
Royal Brisbane Hospital
🇦🇺Brisbane, Queensland, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Algemeen Ziekenhuis Middelheim
🇧🇪Antwerp, Belgium
Institut Jules Bordet
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Gent
🇧🇪Ghent, Belgium
Hopital Universitaire Erasme
🇧🇪Brussels, Belgium
CHR de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Clinique Universitaire De Mont-Godinne
🇧🇪Mont-Godinne Yvoir, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Hopital Edouard Herriot
🇫🇷Lyon, France
Centre Hospitalier Universitaire Henri Mondor
🇫🇷Creteil, France
CHR Hotel Dieu
🇫🇷Nantes, France
Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
Hopital De L'Institut Pasteur
🇫🇷Paris, France
Hotel Dieu de Paris
🇫🇷Paris, France
Hopital Saint-Louis
🇫🇷Paris, France
Hopital Necker
🇫🇷Paris, France
Hopital Robert Debre
🇫🇷Paris, France
Hopital Universitaire Hautepierre
🇫🇷Strasbourg, France
CHRU de Nancy - Hopitaux de Brabois
🇫🇷Vandoeuvre-Les-Nancy, France
Universitaetsklinikum Benjamin Franklin
🇩🇪Berlin, Germany
Medizinische Klinik I
🇩🇪Dresden, Germany
Virchow Klinikum Humboldt Universitaet Berlin
🇩🇪Berlin, Germany
Universitaetskliniken Bonn
🇩🇪Bonn, Germany
Staedtische Kliniken Duisburg
🇩🇪Duisburg, Germany
Stefan Morsch Stiftung
🇩🇪Idar-Oberstein, Germany
Evangelisches Krankenhaus Essen Werden
🇩🇪Essen, Germany
University Medical Center
🇩🇪Freiburg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Martin Luther Universitaet
🇩🇪Halle Saale, Germany
Klinikum Nurnberg
🇩🇪Nuremberg (Nurnberg), Germany
Klinikum Grosshadern
🇩🇪Munich, Germany
Eberhard Karls Universitaet
🇩🇪Tubingen, Germany
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
🇩🇪Munich, Germany
County Hospital
ðŸ‡ðŸ‡ºKaposvar, Hungary
Klinikum der Universitaet Ulm
🇩🇪Ulm, Germany
St. James's Hospital
🇮🇪Dublin, Ireland
National Institute of Haematology and Immunology
ðŸ‡ðŸ‡ºBudapest, Hungary
Karolinska Hospital
🇸🇪Stockholm, Sweden
Hospital Universidad Virgen Del Rocio
🇪🇸Sevilla, Spain
Huddinge Hospital
🇸🇪Stockholm, Sweden
University Hospital
🇨ðŸ‡Basel, Switzerland
Hopital Cantonal Universitaire de Geneva
🇨ðŸ‡Geneva, Switzerland
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
University Medical Center Nijmegen
🇳🇱Nijmegen, Netherlands
Centre Hospitalier Universitaire Vaudois
🇨ðŸ‡Lausanne, Switzerland
University College Hospital
🇬🇧London, England, United Kingdom
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Hadassah University Hospital
🇮🇱Jerusalem, Israel
Addenbrooke's NHS Trust
🇬🇧Cambridge, England, United Kingdom
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Birmingham Heartlands and Solihull NHS Trust (Teaching)
🇬🇧Birmingham, England, United Kingdom