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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00163722
Other study ID # 55/05
Secondary ID ALLG SC01NHMRC P
Status Completed
Phase Phase 3
First received September 11, 2005
Last updated February 17, 2013
Start date September 2005
Est. completion date August 2011

Study information

Verified date September 2005
Source Bayside Health
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date August 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
Culture and histology

Aspergillus galactomannan and PCR


Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Alfred Hospital Melbourne Victoria
Australia Peter MacCallum Cancer Centre Melbourne Victoria
Australia Royal Melbourne Hospital Melbourne Victoria
Australia St. Vincent's Hospital Sydney New South Wales
Australia Westmead Hospital Sydney New South Wales

Sponsors (2)

Lead Sponsor Collaborator
Bayside Health National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Other Sub-group analysis according to type of antifungal prophylaxis, underlying disease and centre 26 weeks of follow-up No
Primary The proportion of patients treated with at least 1 course of empiric antifungal therapy as per protocol definition at 26 weeks following randomisation 26 weeks of follow-up No
Secondary Invasive Aspergillosis related mortality rates 26 weeks of follow-up No
Secondary Other invasive fungal infection-related (IFI) mortality rates 26 weeks of follow-up No
Secondary All-cause mortality rates 26 weeks of follow-up No
Secondary Nephrotoxicity rates 26 weeks of follow-up Yes
Secondary Hepatotoxicity rates 26 weeks of follow-up Yes
Secondary Total number of courses of empiric antifungal therapy 26 weeks of follow-up No
Secondary Cost data associated with treatment and complications. To include number of hospital admissions, hospital length of stay, total duration of antifungal therapy and number of invasive procedures to diagnose invasive aspergillosis 26 weeks of follow-up No
Secondary Incidence of proven, probable and possible invasive aspergillosis 26 weeks of follow-up No
Secondary Incidence of proven, probable and possible other invasive fungal disease besides invasive aspergillosis 26 weeks of follow-up No
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Completed NCT00334412 - COMBISTRAT: AmBisome® in Combination With Caspofungin for the Treatment of Invasive Aspergillosis Phase 4
Completed NCT04550936 - Patterns of Real-World Isavuconazole Use - a Study of Patients With Mucormycosis or Invasive Aspergillosis