Comparison of Voriconazole and Amphotericin B in Treating Patients With Aspergillosis

NCT00003031 | Completed Phase 3

• 2 other identifiers: EORTC-19961PFIZER-150-307-000
• Study Type: interventional
• Target: 212
• Locations: 15 countries
• Sites: 74

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.

Conditions

Infection; Pulmonary Complications

Keywords

infection; pulmonary complications

Interventions

amphotericin B deoxycholate DRUG

voriconazole DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Patient immunocompromised as the result of any of the following: Allogeneic bone marrow/peripheral stem cell transplant Autologous bone marrow/peripheral stem cell transplant Hematological malignancy (including lymphoma) Aplastic anemia and myelodysplastic syndromes (currently on immunosuppressive treatment) Solid organ transplantation (other than lung) Other solid organ malignancy (after cytotoxic chemotherapy) HIV/AIDS High dose prolonged corticosteroid therapy (at least 20 mg/day of prednisolone or equivalent for more than 3 weeks) or prolonged therapy with other immunosuppressive agents (e.g., azathioprine, methotrexate) Diagnosis of either definite or probable acute invasive aspergillosis Fungal infection represents a new episode of acute invasive aspergillosis Patients with the following are ineligible: Aspergilloma or allergic bronchopulmonary aspergillosis Chronic invasive aspergillosis Sarcoidosis CMV pneumonia PATIENT CHARACTERISTICS: Age: 12 and over Life expectancy: At least 72 hours Hematopoietic: Not specified Hepatic: Bilirubin no greater than 5 times upper limit of normal (ULN) SGOT/SGPT no greater than 5 times ULN Alkaline phosphatase no greater than 5 times ULN Renal: Creatinine no greater than 2.5 mg/dL Other: No history of hypersensitivity or intolerance to azole antifungal agents including miconazole, ketoconazole, fluconazole, or itraconazole No history of hypersensitivity or severe intolerance to conventional or lipid formulations of amphotericin B Not pregnant or nursing Fertile women must use effective contraception Negative pregnancy test No prior participation on this trial Not on artificial ventilation and unlikely to be extubated within 24 hours No condition that could affect patient safety, preclude evaluation of response, or make study completion unlikely PRIOR CONCURRENT THERAPY: At least 8 weeks since prior systemic treatment with amphotericin B or itraconazole At least 2 weeks since prior systemic antifungal therapy for more than 96 hours at doses greater than 0.5 mg/kg/day for conventional or lipid formulations of amphotericin B or greater than 200 mg/day of itraconazole No concurrent drugs that are metabolized primarily by hepatic cytochrome P-450 enzymes or which induce or inhibit these enzymes, such as terfenadine, loratidine, astemizole, midazolam, triazolam, cisapride, rifampin, rifabutin, barbiturates, carbamazepine, coumarins, sulfonylureas, nivarapine, erythromycin, ritonavir, delaviridine, omeprazole, and phenytoin At least 2 weeks since prior rifampin, rifabutin, carbamazepine, or barbiturates for more than 3 days No concurrent investigational drugs other than cytotoxics, antiretroviral agents, or therapies for AIDS-related opportunistic infection No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) other than for treatment of granulocytopenia No concurrent white blood cell transfusions No concurrent systemic antifungal agents active against Aspergillus spp. (e.g., itraconazole, lipid formulations of amphotericin B, or flucytosine)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (74)

Hartford Medical Group

Wethersfield, Connecticut, 06109, United States

Location

St. Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Royal Brisbane Hospital

Brisbane, Queensland, 4029, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3181, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Algemeen Ziekenhuis Middelheim

Antwerp, 2020, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Clinique Universitaire De Mont-Godinne

Mont-Godinne Yvoir, 5530, Belgium

Location

CHR de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94010, France

Location

Hopital Du Bocage

Dijon, 21034, France

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

CHR Hotel Dieu

Nantes, 44093, France

Location

Hopital De L'Institut Pasteur

Paris, 75015, France

Location

Hopital Robert Debre

Paris, 75019, France

Location

Hotel Dieu de Paris

Paris, 75181, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

Hopital Necker

Paris, 75743, France

Location

Hopital Universitaire Hautepierre

Strasbourg, 67098, France

Location

CHRU de Nancy - Hopitaux de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Universitaetsklinikum Benjamin Franklin

Berlin, D-12200, Germany

Location

Virchow Klinikum Humboldt Universitaet Berlin

Berlin, D-13353, Germany

Location

Universitaetskliniken Bonn

Bonn, D-53127, Germany

Location

Medizinische Klinik I

Dresden, D-01307, Germany

Location

Staedtische Kliniken Duisburg

Duisburg, D-47055, Germany

Location

Evangelisches Krankenhaus Essen Werden

Essen, D-45239, Germany

Location

University Medical Center

Freiburg im Breisgau, D-79106, Germany

Location

Martin Luther Universitaet

Halle, DOH-0-6112, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Stefan Morsch Stiftung

Idar-Oberstein, D-55743, Germany

Location

Klinikum Grosshadern

Munich, D-81377, Germany

Location

Klinikum Rechts Der Isar/Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Klinikum Nurnberg

Nuremberg (Nurnberg), D-90419, Germany

Location

Eberhard Karls Universitaet

Tübingen, D-72076, Germany

Location

Klinikum der Universitaet Ulm

Ulm, D-89081, Germany

Location

Szent Laszlo Korhaz

Budapest, 1097, Hungary

Location

National Institute of Haematology and Immunology

Budapest, H-1519, Hungary

Location

County Hospital

Kaposvár, H-7400, Hungary

Location

St. James's Hospital

Dublin, 8, Ireland

Location

Hadassah University Hospital

Jerusalem, 91120, Israel

Location

Ospedale San Orsola

Bologna, 40138, Italy

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa, 16132, Italy

Location

Ospedale Maggiore Ca Granda

Milan, 20162, Italy

Location

University and I.R.C.C.S. Policlinico San Matteo

Pavia, 27100, Italy

Location

Policlinico Monteluce

Perugia, 06122, Italy

Location

Ospedale Civile Pescara

Pescara, 65100, Italy

Location

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

Centre Hospitalier de Luxembourg

Luxembourg, 1210, Luxembourg

Location

Leiden University Medical Center

Leiden, 2300 ZA, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6252 HB, Netherlands

Location

Hospital de Cruces

Barakaldo, Bilbao, E-48903, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Hospital Clinic y Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital General Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Universitasrio San Carlos

Madrid, 28040, Spain

Location

University Hospital - Salamanca

Salamanca, 37007, Spain

Location

Hospital Universidad Virgen Del Rocio

Seville, E- 41013, Spain

Location

Huddinge Hospital

Stockholm, S-141 86, Sweden

Location

Karolinska Hospital

Stockholm, S-171 76, Sweden

Location

University Hospital

Basel, CH-4031, Switzerland

Location

Hopital Cantonal Universitaire de Geneva

Geneva, CH-1211, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Birmingham Heartlands and Solihull NHS Trust (Teaching)

Birmingham, England, B9 5SS, United Kingdom

Location

Addenbrooke's NHS Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

King's College Hospital

London, England, SE5 9RS, United Kingdom

Location

University College Hospital

London, England, WC1E 6AU, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

North Manchester Healthcare NHS Trust

Manchester, M8 6RB, United Kingdom

Location

MeSH Terms

Conditions

Infections

Interventions

amphotericin B, deoxycholate drug combination; Voriconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• R. Herbrecht, MD

  Hopital Universitaire Hautepierre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 27, 2004
• Study Start: June 1, 1997
• Primary Completion: October 1, 2000
• Last Updated: July 2, 2012

Record last verified: 2012-06

Locations

SE (2); IL (1); IE (1); GB (7); FR (13); DE (15); IT (7); LU (1); HU (3); NL (2); US (1); ES (7); AU (4); BE (7); CH (3)