Data

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 data
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Subjects

Infectious diseases |

Related Study

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

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 leukaemia or acute lymphoblastic leukaemia. The study aims to determine which strategy results in lower: rates of empiric antifungal therapy administration; drug–related toxicities; IA-related mortality rates and overall mortality rates.

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.

Study Type

  • Interventional

Ethics Approval

Study Protocol: Available
Data Dictionary: Not Available

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