A Multicentre Randomised Controlled Trial Comparing Two Strategies for the Diagnosis of Invasive Aspergillosis in High-Risk Haematology Patients (SC01)
Australasian Leukaemia and Lymphoma Group (ALLG)Dataset description
Dataset includes Data for 240 patients Data for patients with various heamatological malignancy, assessing response to two strategies for diagnosing lung infection with Aspergillus Demographic data, diagnostic data, treatment data, outcome dataSubjects
Infectious diseases |Identifiers
Source Study
Trial name (public)
A Multicentre Randomised Controlled Trial Comparing Two Strategies for the Diagnosis of Invasive Aspergillosis in High-Risk Haematology PatientsTrial acronym
ASPID
Trial ID
ACTRN12605000137695
Purpose
Diagnosis
Phase
Phase 3
Funding
Government body,NHMRC project grant
Scientific enquiries
Dr. Monica Slavin
Brief Summary
This randomised controlled trial compares the new diagnostic strategy for Invasive Aspergillosis (IA) to the current standard diagnostic strategy. The new diagnostic strategy uses Aspergillus ELISA and an Aspergillus nested PCR assay to diagnose/exclude IA and direct further management including timing of HRCT scan of thorax. Eligible patients are aged 18-80 and have received an allogeneic haematopoietic stem cell transplant or are undergoing intensive combination chemotherapy for acute myeloid .... Read more
Key Inclusion Criteria
1.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). 2.Has given written informed consent. Non-English speaking patients are eligible once written informed consent is obtained via the appropriate interpreter.
Key Exclusion Criteria
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 th .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 240
Min. age 18 Years
Max. age 80 Years
Sex Both males and females
Condition category Invasive Aspergillosis
Condition code Blood , Infection
Intervention
Intervention code Diagnosis / Prognosis
Study design: A multicentre, randomised parallel-group trial which compares 2 strategies for the diagnosis of Invasive Aspergillosis (IA) in patients undergoing allogeneic haematopoietic stem cell transplantation (HSCT) and in patients undergoing intensive combination chemotherapy for acute leukaemia. Eligible patients will be stratified by centre and randomised 1:1 to the either the current standard diagnostic strategy (comparator or control arm) or the new diagnostic strategy (intervention arm .... Read more
Comparison
Control group Active
Current standard diagnostic strategy (comparator or control arm)
Outcomes
Outcome: The proportion of patients treated with at least 1 course of empiric antifungal therapy as per protocol definitionTimepoint: At 26 weeks following randomisation
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
De-identified IPD data, for all data collected during the trial
When will data be available?
Data available 3 months following publication, for an indefinite period
Available to whom?
Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Available for what types of analyses?
Any type of analysis Assessed on a case-by-case basis