InfectionPhase 3NCT00003031
Comparison of Voriconazole and Amphotericin B in Treating Patients With Aspergillosis
A Phase 3 study testing amphotericin B deoxycholate and voriconazole in people with Infection and Pulmonary Complications, run by European Organisation for Research and Treatment of Cancer - EORTC at 74 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Infection, Pulmonary Complications
- What is being tested?
- amphotericin B deoxycholate and voriconazole
- How many people
- 212 participants
- Where
- 74 sitesin 15 countries
- Study dates
- Jun 1997to Oct 2000
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Trial locations and contacts
74 sites in 15 countries.
74 sites in 15 countries
Germany15 sites
Universitaetsklinikum Benjamin Franklin
Berlin, D-12200
Virchow Klinikum Humboldt Universitaet Berlin
Berlin, D-13353
Universitaetskliniken Bonn
Bonn, D-53127
Medizinische Klinik I
Dresden, D-01307
Staedtische Kliniken Duisburg
Duisburg, D-47055
Evangelisches Krankenhaus Essen Werden
Essen, D-45239
University Medical Center
Freiburg im Breisgau, D-79106
Martin Luther Universitaet
Halle, DOH-0-6112
Medizinische Hochschule Hannover
Hanover, D-30625
Stefan Morsch Stiftung
Idar-Oberstein, D-55743
Klinikum Grosshadern
Munich, D-81377
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
Munich, D-81675
Klinikum Nurnberg
Nuremberg (Nurnberg), D-90419
Eberhard Karls Universitaet
Tübingen, D-72076
Klinikum der Universitaet Ulm
Ulm, D-89081
France13 sites
CHR de Besancon - Hopital Jean Minjoz
Besançon, 25030
Centre Hospitalier Universitaire Henri Mondor
Créteil, 94010
Hopital Du Bocage
Dijon, 21034
Hopital Edouard Herriot
Lyon, 69437
Institut J. Paoli and I. Calmettes
Marseille, 13273
CHR Hotel Dieu
Nantes, 44093
Hopital De L'Institut Pasteur
Paris, 75015
Hopital Robert Debre
Paris, 75019
Hotel Dieu de Paris
Paris, 75181
Hopital Saint-Louis
Paris, 75475
Hopital Necker
Paris, 75743
Hopital Universitaire Hautepierre
Strasbourg, 67098
CHRU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy, 54511
Belgium7 sites
Algemeen Ziekenhuis Middelheim
Antwerp, 2020
Institut Jules Bordet
Brussels, 1000
Hopital Universitaire Erasme
Brussels, 1070
Universitair Ziekenhuis Antwerpen
Edegem, B-2650
Universitair Ziekenhuis Gent
Ghent, B-9000
U.Z. Gasthuisberg
Leuven, B-3000
Clinique Universitaire De Mont-Godinne
Mont-Godinne Yvoir, 5530
Italy7 sites
Ospedale San Orsola
Bologna, 40138
Istituto Nazionale per la Ricerca sul Cancro
Genoa, 16132
Ospedale Maggiore Ca Granda
Milan, 20162
University and I.R.C.C.S. Policlinico San Matteo
Pavia, 27100
Policlinico Monteluce
Perugia, 06122
Ospedale Civile Pescara
Pescara, 65100
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, 00168
Spain7 sites
Hospital de Cruces
Barakaldo, Bilbao, E-48903
Hospital Del Mar
Barcelona, 08003
Hospital Clinic y Provincial de Barcelona
Barcelona, 08036
Hospital General Gregorio Maranon
Madrid, 28007
Hospital Universitasrio San Carlos
Madrid, 28040
University Hospital - Salamanca
Salamanca, 37007
Hospital Universidad Virgen Del Rocio
Seville, E- 41013
United Kingdom7 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Birmingham Heartlands and Solihull NHS Trust (Teaching)
Birmingham, England, B9 5SS
Royal Bournemouth Hospital
Bournemouth, BH7 7DW
Addenbrooke's NHS Trust
Cambridge, England, CB2 2QQ
King's College Hospital
London, England, SE5 9RS
University College Hospital
London, England, WC1E 6AU
North Manchester Healthcare NHS Trust
Manchester, M8 6RB
Australia4 sites
Royal Brisbane Hospital
Brisbane, Queensland, 4029
Alfred Hospital
Melbourne, Victoria, 3181
Royal Melbourne Hospital
Parkville, Victoria, 3050
St. Vincent's Hospital
Sydney, New South Wales, 2010
Hungary3 sites
Szent Laszlo Korhaz
Budapest, 1097
National Institute of Haematology and Immunology
Budapest, H-1519
County Hospital
Kaposvár, H-7400
Switzerland3 sites
University Hospital
Basel, CH-4031
Hopital Cantonal Universitaire de Geneva
Geneva, CH-1211
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
Netherlands2 sites
Leiden University Medical Center
Leiden, 2300 ZA
University Medical Center Nijmegen
Nijmegen, NL-6252 HB
Sweden2 sites
Huddinge Hospital
Stockholm, S-141 86
Karolinska Hospital
Stockholm, S-171 76
United States1 site
Hartford Medical Group
Wethersfield, Connecticut, 06109
About this study
Official title: An Open Randomised Comparative Multicentre Study of the Efficacy, Safety and Toleration of Voriconazole Versus Amphotericin-B in the Treatment of Acute Invasive Aspergillosis in Immunocompromised Patients
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.
Read the 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.
- Conditions
- Infection, Pulmonary Complications
- Being tested
- amphotericin B deoxycholate, voriconazole
- Keywords
- infection, pulmonary complications
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amphotericin B deoxycholateDrug
voriconazoleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2004 (estimated)
- Study startJun 1997
- Primary completionOct 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- R. Herbrecht, MD, Study chair, Hopital Universitaire Hautepierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003031
- Sponsor's protocol ID
- EORTC-19961
- Other IDs
- EORTC-19961, PFIZER-150-307-000
- Status last verified
- Jun 2012
- First submitted
- 1 Nov 1999
- Last updated
- 2 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Randomised Comparative Multicentre Study of the Efficacy, Safety and Toleration of Voriconazole Versus Amphotericin-B in the Treatment of Acute Invasive Aspergillosis in Immunocompromised Patients
- ClinicalTrials.gov ID
- NCT00003031
- Acronym / sponsor ID
- EORTC-19961
- Conditions
- Infection, Pulmonary Complications
- Keywords
- infection, pulmonary complications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Jun 1997
- Primary completion
- Oct 2000 (actual)
- First posted
- 27 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amphotericin B deoxycholate | Drug | – |
| voriconazole | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Herbrecht, MD study chair
Hopital Universitaire Hautepierre
74 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing amphotericin B deoxycholate and voriconazole in people with Infection and Pulmonary Complications, run by European Organisation for Research and Treatment of Cancer - EORTC at 74 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in Germany, France, Belgium, Italy, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2012.