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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00003031




Registration number
NCT00003031
Ethics application status
Date submitted
1/11/1999
Date registered
27/05/2004
Date last updated
2/07/2012

Titles & IDs
Public title
Comparison of Voriconazole and Amphotericin B in Treating Patients With Aspergillosis
Scientific 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
Secondary ID [1] 0 0
EORTC-19961
Secondary ID [2] 0 0
EORTC-19961
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infection 0 0
Pulmonary Complications 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - amphotericin B deoxycholate
Treatment: Drugs - voriconazole

Treatment: Drugs: amphotericin B deoxycholate


Treatment: Drugs: voriconazole
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion 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

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)
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Supportive Care
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/1997
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
212
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Brisbane Hospital - Brisbane
Recruitment hospital [3] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
3181 - Melbourne
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
Belgium
State/province [2] 0 0
Antwerp
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels
Country [4] 0 0
Belgium
State/province [4] 0 0
Edegem
Country [5] 0 0
Belgium
State/province [5] 0 0
Ghent
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Belgium
State/province [7] 0 0
Mont-Godinne Yvoir
Country [8] 0 0
France
State/province [8] 0 0
Besancon
Country [9] 0 0
France
State/province [9] 0 0
Creteil
Country [10] 0 0
France
State/province [10] 0 0
Dijon
Country [11] 0 0
France
State/province [11] 0 0
Lyon
Country [12] 0 0
France
State/province [12] 0 0
Marseille
Country [13] 0 0
France
State/province [13] 0 0
Nantes
Country [14] 0 0
France
State/province [14] 0 0
Paris
Country [15] 0 0
France
State/province [15] 0 0
Strasbourg
Country [16] 0 0
France
State/province [16] 0 0
Vandoeuvre-Les-Nancy
Country [17] 0 0
Germany
State/province [17] 0 0
Berlin
Country [18] 0 0
Germany
State/province [18] 0 0
Bonn
Country [19] 0 0
Germany
State/province [19] 0 0
Dresden
Country [20] 0 0
Germany
State/province [20] 0 0
Duisburg
Country [21] 0 0
Germany
State/province [21] 0 0
Essen
Country [22] 0 0
Germany
State/province [22] 0 0
Freiburg
Country [23] 0 0
Germany
State/province [23] 0 0
Halle Saale
Country [24] 0 0
Germany
State/province [24] 0 0
Hannover
Country [25] 0 0
Germany
State/province [25] 0 0
Idar-Oberstein
Country [26] 0 0
Germany
State/province [26] 0 0
Munich
Country [27] 0 0
Germany
State/province [27] 0 0
Nuremberg (Nurnberg)
Country [28] 0 0
Germany
State/province [28] 0 0
Tubingen
Country [29] 0 0
Germany
State/province [29] 0 0
Ulm
Country [30] 0 0
Hungary
State/province [30] 0 0
Budapest
Country [31] 0 0
Hungary
State/province [31] 0 0
Kaposvar
Country [32] 0 0
Ireland
State/province [32] 0 0
Dublin
Country [33] 0 0
Israel
State/province [33] 0 0
Jerusalem
Country [34] 0 0
Italy
State/province [34] 0 0
Bologna
Country [35] 0 0
Italy
State/province [35] 0 0
Genoa
Country [36] 0 0
Italy
State/province [36] 0 0
Milan
Country [37] 0 0
Italy
State/province [37] 0 0
Pavia
Country [38] 0 0
Italy
State/province [38] 0 0
Perugia
Country [39] 0 0
Italy
State/province [39] 0 0
Pescara
Country [40] 0 0
Italy
State/province [40] 0 0
Rome
Country [41] 0 0
Luxembourg
State/province [41] 0 0
Luxembourg
Country [42] 0 0
Netherlands
State/province [42] 0 0
Leiden
Country [43] 0 0
Netherlands
State/province [43] 0 0
Nijmegen
Country [44] 0 0
Spain
State/province [44] 0 0
Barakaldo, Bilbao
Country [45] 0 0
Spain
State/province [45] 0 0
Barcelona
Country [46] 0 0
Spain
State/province [46] 0 0
Madrid
Country [47] 0 0
Spain
State/province [47] 0 0
Salamanca
Country [48] 0 0
Spain
State/province [48] 0 0
Sevilla
Country [49] 0 0
Sweden
State/province [49] 0 0
Stockholm
Country [50] 0 0
Switzerland
State/province [50] 0 0
Basel
Country [51] 0 0
Switzerland
State/province [51] 0 0
Geneva
Country [52] 0 0
Switzerland
State/province [52] 0 0
Lausanne
Country [53] 0 0
United Kingdom
State/province [53] 0 0
England
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Scotland
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Bournemouth
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Other
Name
European Organisation for Research and Treatment of Cancer - EORTC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00003031
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
R. Herbrecht, MD
Address 0 0
Hopital Universitaire Hautepierre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00003031