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Home > "C" Clinical Trials Conditions > Comparison of Voriconazole and Amphotericin B in Treating Patients With Aspergillosis  Comparison of Voriconazole and Amphotericin B in Treating Patients With Aspergillosis
Comparison of Voriconazole and Amphotericin B in Treating Patients With Aspergillosis
For Condition: Pulmonary Complications,Infection
Status: No longer recruiting
Sponsor(s): EORTC Invasive Fungal Infections Cooperative Group ,
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 12 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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) --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
R.Herbrecht, Study Chair, EORTC Invasive Fungal Infections Cooperative Group
Hopital Cantonal Universitaire de Geneva
Geneva, , CH-1211
Switzerland
CHR de Besancon - Hopital Jean Minjoz
Besancon, , 25030
France
Institut Jules Bordet
Brussels, , 1000
Belgium
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Huddinge Hospital
Stockholm, , S-141 86
Sweden
Szent Laszlo Korhaz
Budapest, , 1097
Hungary
Hotel Dieu de Paris
Paris, , 75181
France
University and I.R.C.C.S. Policlinico San Matteo
Pavia, , 27100
Italy
Eberhard Karls Universitaet
Tubingen, , D-72076
Germany
Universitaetskliniken Bonn
Bonn, , D-53127
Germany
Policlinico Monteluce
Perugia, , 06122
Italy
Hopital De L'Institut Pasteur
Paris, , 75015
France
Addenbrooke's NHS Trust
Cambridge, England, CB2 2QQ
United Kingdom
Universitair Ziekenhuis Gent
Ghent, , B-9000
Belgium
Hopital Du Bocage
Dijon, , 21034
France
Stefan Morsch Stiftung
Idar-Oberstein, , D-55743
Germany
University Medical Center
Freiburg, , D-79106
Germany
Hadassah University Hospital
Jerusalem, , 91120
Israel
National Institute of Haematology and Immunology
Budapest, , H-1519
Hungary
Virchow Klinikum Humboldt Universitaet Berlin
Berlin, , D-13353
Germany
University Medical Center Nijmegen
Nijmegen, , NL-6252 HB
Netherlands
Ospedale Civile Pescara
Pescara, , 65100
Italy
Klinikum der Universitaet Ulm
Ulm, , D-89081
Germany
Royal Bournemouth Hospital
Bournemouth, , BH7 7DW
United Kingdom
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, , 00168
Italy
Hopital Necker
Paris, , 75743
France
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
Munich, , D-81675
Germany
St. James's Hospital
Dublin, , 8
Ireland
Hospital General Gregorio Maranon
Madrid, , 28007
Spain
Birmingham Heartlands and Solihull NHS Trust (Teaching)
Birmingham, England, B9 5SS
United Kingdom
Hospital Clinic y Provincial de Barcelona
Barcelona, , 08036
Spain
Institut J. Paoli and I. Calmettes
Marseille, , 13273
France
Hospital de Cruces
Barakaldo, Bilbao, , E-48903
Spain
Centre Hospitalier Universitaire Henri Mondor
Creteil, , 94010
France
Hopital Robert Debre
Paris, , 75019
France
Clinique Universitaire De Mont-Godinne
Mont-Godinne Yvoir, , 5530
Belgium
Hopital Universitaire Hautepierre
Strasbourg, , 67098
France
Hopital Universitaire Erasme
Brussels, , 1070
Belgium
Klinikum Nurnberg
Nuremberg (Nurnberg), , D-90419
Germany
University Hospital
Basel, , CH-4031
Switzerland
Hospital Universidad Virgen Del Rocio
Sevilla, , E- 41013
Spain
Martin Luther Universitaet
Halle Saale, , DOH-0-6112
Germany
Ospedale Maggiore Ca Granda
Milan, , 20162
Italy
Hopital Saint-Louis
Paris, , 75475
France
Ospedale San Orsola
Bologna, , 40138
Italy
Istituto Nazionale per la Ricerca sul Cancro
Genoa, , 16132
Italy
Algemeen Ziekenhuis Middelheim
Antwerp, , 2020
Belgium
Centre Hospitalier Universitaire Vaudois
Lausanne, , CH-1011
Switzerland
Karolinska Hospital
Stockholm, , S-171 76
Sweden
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Centre Hospitalier de Luxembourg
Luxembourg, , 1210
Luxembourg
Leiden University Medical Center
Leiden, , 2300 ZA
Netherlands
County Hospital
Kaposvar, , H-7400
Hungary
Klinikum Grosshadern
Munich, , D-81377
Germany
University Hospital - Salamanca
Salamanca, , 37007
Spain
Hospital Universitasrio San Carlos
Madrid, , 28040
Spain
Royal Brisbane Hospital
Brisbane, Queensland, 4029
Australia
King's College Hospital
London, England, SE5 9RS
United Kingdom
Royal Melbourne Hospital
Parkville, Victoria, 3050
Australia
Alfred Hospital
Melbourne, Victoria, 3181
Australia
Medizinische Hochschule Hannover
Hannover, , D-30625
Germany
Medizinische Klinik I
Dresden, , D-01307
Germany
CHR Hotel Dieu
Nantes, , 44093
France
Hospital Del Mar
Barcelona, , 08003
Spain
Hopital Edouard Herriot
Lyon, , 69437
France
Staedtische Kliniken Duisburg
Duisburg, , D-47055
Germany
Hartford Medical Group
Wethersfield, Connecticut, 06109
United States
University College Hospital
London, England, WC1E 6AU
United Kingdom
Evangelisches Krankenhaus Essen Werden
ESSEN, , D-45239
Germany
Universitaetsklinikum Benjamin Franklin
Berlin, , D-12200
Germany
CHRU de Nancy - Hopitaux de Brabois
Vandoeuvre-les-Nancy, , 54511
France
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
United Kingdom
North Manchester Healthcare NHS Trust
Manchester, , M8 6RB
United Kingdom
St. Vincent's Hospital
Sydney, New South Wales, 2010
Australia
Additional Information:
Study ID Numbers: CDR0000065627; EORTC-19961,PFIZER-150-307-000
Study Start Date: June 1997
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003031
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3. Captopril in Treating Patients With Non-Small Cell Lung Cancer or Limited-Stage Small Cell Lung Cancer That Has Been Previously Treated With Radiation Therapy With or Without Chemotherapy
4. Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer
5. Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
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Comparison of Voriconazole and Amphotericin B in Treating Patients With Aspergillosis
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