A Multicentre Randomised Controlled Trial Comparing Two Strategies for the Diagnosis of Invasive Aspergillosis in High-Risk Haematology Patients

A Multicentre Randomised Controlled Trial Comparing Two Strategies for the Diagnosis of Invasive Aspergillosis in High-Risk Haematology Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Bayside Health.   Recruitment status was  Recruiting

First Received on September 11, 2005.  
Last Updated on October 2, 2006  
History of Changes
Sponsor: Bayside Health
Collaborator: National Health and Medical Research Council, Australia
Information provided by: Bayside Health
ClinicalTrials.gov Identifier: NCT00163722
  Purpose

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
Invasive Aspergillosis Device: Aspergillus galactomannan ELISA and Aspergillus PCR assay Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

Further study details as provided by Bayside Health:

Primary Outcome Measures:

  • The proportion of patients treated with at least 1 course of empiric antifungal therapy as per protocol definition at 26 weeks following randomisation

Secondary Outcome Measures:

  • Invasive Aspergillosis related mortality rates
  • Other invasive fungal infection-related (IFI) mortality rates
  • All-cause mortality rates
  • Mean number of hospital admissions
  • Median hospital length of stay
  • Total duration of antifungal therapy
  • Nephrotoxicity rates
  • Hepatotoxicity rates
  • Median number of courses of empiric antifungal therapy
  • Median number of invasive procedures performed to diagnose IA
  • Cost data associated with treatment and complications.
  • All secondary outcomes will be measured at 26 weeks post randomisation

Estimated Enrollment: 600
Study Start Date: September 2005
Estimated Study Completion Date: March 2009

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163722

Contacts
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

Locations
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            
Sponsors and Collaborators
Bayside Health
National Health and Medical Research Council, Australia
Investigators
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
  More Information

Additional Information:

No publications provided by Bayside Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00163722    
History of Changes
Other Study ID Numbers: 55/05, ALLG SC01, NHMRC Project Grant 331305
Study First Received: September 11, 2005
Last Updated: October 2, 2006
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:

Aspergillosis
Mycoses

ClinicalTrials.gov processed this record on August 21, 2012

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