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Sponsors and Collaborators: |
Bayside Health National Health and Medical Research Council, Australia |
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Information provided by: | Bayside Health |
ClinicalTrials.gov Identifier: | NCT00163722 |
Aspergillus is a fungus found in soil, on farms and on construction sites. In those whose immune system is impaired it causes severe infection. The people who are particularly at high-risk of infection with Aspergillus (which is called Invasive Aspergillosis)are those with acute leukaemia who are having chemotherapy and those post bone marrow transplantation. Currently 15% of those at high-risk develop Invasive Aspergillosis and 60-90% of those with Invasive Aspergillosis die.
The main reason for this high death rate is that our current diagnostic tests are not good at detecting infection or often only detect the infection at advanced stages when treatment is ineffective. Because of the limitations of current diagnostic tests the current practice is to give empiric antifungal therapy (EAFT) early to treat suspected Invasive Aspergillosis. However studies have demonstrated that this therapy has only resulted in a minor reduction in the mortality rates and it also causes significant drug toxicity. It is a suboptimal treatment modality.
New tests have recently been developed to diagnose Invasive Aspergillosis. These tests are for the detection of an Aspergillus protein in blood and for the detection of Aspergillus DNA in blood. Available data suggests that these new tests make an early diagnosis and seem to be able to monitor responses to treatment. However no study has been reported to date which demonstrates that the use of these tests can impact on important patient outcomes. This trial is being performed to determine whether the use of the new diagnostic tests to guide antifungal therapy will help improve treatment of Invasive Aspergillosis, reduce drug toxicity and reduce the death rate in the high-risk patients as compared with the current standard method of diagnosis and treatment with EAFT.
Condition | Intervention | Phase |
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Invasive Aspergillosis |
Device: Aspergillus galactomannan ELISA and Aspergillus PCR assay |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multicentre Randomised Controlled Trial Comparing the Current Standard Diagnostic Strategy for Invasive Aspergillosis to the New Diagnostic Strategy for Invasive Aspergillosis in High-Risk Haematology Patients in Order to Determine Which Strategy Results in the Lower Rates of Use of Empiric Antifungal Therapy |
Estimated Enrollment: | 600 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | March 2009 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients fulfilling all the following criteria will be eligible for enrolment 1. Aged 18-80 years 2. Undergoing allogeneic haematopoietic stem cell transplantation (HSCT) for any reason OR Undergoing intensive combination chemotherapy for acute myeloid leukaemia (AML) or acute lymphoblastic leukaemia (ALL) 3. Has given written informed consent.
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Exclusion Criteria:
Patients with any of the following will be ineligible for enrolment 1. Other immunocompromised states (e.g. HIV infection, solid organ transplantation, autoimmune conditions treated with immunosuppressants etc.) besides those outlined in the inclusion criteria above 2. Currently enrolled in an antifungal treatment trial (not an antifungal prophylaxis trial) 3. Past history of proven or probable IA (as per standardized definitions) during a previous cycle of chemotherapy 4. Currently have active IA or other active invasive fungal infection 5. Prior enrolment in this study
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Contact: Orla Morrissey, MB BCh FRACP | 61 3 9276 2000 ext 2631 | o.morrissey@alfred.org.au |
Contact: Monica Slavin, MB BS FRACP | 61 3 9656 1111 ext 1526 | Monica.Slavin@petermac.org |
Australia, New South Wales | |
Westmead Hospital | Recruiting |
Sydney, New South Wales, Australia, 2145 | |
Contact: Tania Sorrell, MD BS FRACP 61 2 9845 7191 ext 7191 tanias@icpmr.wsahs.nsw.gov.au | |
Contact: Sharon Chen, MB BS FRACP 61 2 9845 6255 ext 6255 sharonc@icpmr.wsahs.nsw.gov.au | |
Principal Investigator: Tania Sorrell, MD BS FRACP | |
St. Vincent's Hospital | Not yet recruiting |
Sydney, New South Wales, Australia, 2010 | |
Contact: Sam Milliken, MB BS FRACP 61 2 8382 2697 smilliken@stvincents.com.au | |
Contact: Rachelle Carter, RN 61 2 8382 2697 rcarter@stvincents.com.au | |
Principal Investigator: Sam Milliken, MB BS FRACP | |
Australia, Victoria | |
Alfred Hospital | Recruiting |
Melbourne, Victoria, Australia, 3004 | |
Contact: Orla Morrissey, MB BCh FRAP 61 3 9276 2000 ext 2631 o.morrissey@alfred.org.au | |
Contact: Tim Luff, RN 61 3 9207 1884 ext 1884 t.luff@alfred.org.au | |
Principal Investigator: Orla Morrissey, MB BCh FRACP | |
Royal Melbourne Hospital | Recruiting |
Melbourne, Victoria, Australia, 3052 | |
Contact: Monica Slavin, MB BS FRACP 61 3 9342 7000 ext 7212 Monica.Slavin@mh.org.au | |
Contact: Tim Luff, RN 61 3 9342 7000 ext 8896 Tim.Luff@mh.org.au | |
Principal Investigator: Monica Slavin, MB BS FRACP | |
Peter MacCallum Cancer Centre | Not yet recruiting |
Melbourne, Victoria, Australia, 3002 | |
Contact: Monica Slavin, MB BS FRACP 61 3 9656 1111 ext 1526 Monica.Slavin@petermac.org | |
Contact: Miles Prince, MD FRACP 61 3 9656 1111 ext 1700 Miles.Prince@petermac.org | |
Principal Investigator: Monica Slavin, MB BS FRACP |
Principal Investigator: | Monica Slavin, MB BS FRACP | Infectious Diseases Unit, Peter MacCallum Cancer Centre, St. Andrew's Place, East Melbourne, Victoria, Australia |
Principal Investigator: | Orla Morrissey, MB BCh FRACP | Infectious Diseases Unit, Alfred Hospital, Level 2, Burnet Institute, Commercial Road, Melbourne, Victoria, 3004, Australia |
Study ID Numbers: | 55/05, ALLG SC01, NHMRC Project Grant 331305 |
Study First Received: | September 11, 2005 |
Last Updated: | October 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00163722 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Mycoses Clotrimazole Miconazole Tioconazole Aspergillosis |