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Observational study to determine the rate of occurrence of invasive mould disease and treatment outcomes in at-risk patients: a European prospective invasive.

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Presentation on theme: "Observational study to determine the rate of occurrence of invasive mould disease and treatment outcomes in at-risk patients: a European prospective invasive."— Presentation transcript:

1 Observational study to determine the rate of occurrence of invasive mould disease and treatment outcomes in at-risk patients: a European prospective invasive mould disease audit ( PIMDA)

2 Primary aim To estimate the rate of occurrence of possible, probable and proven invasive mould disease (IMD) in patients who are expected to develop neutropenia of at least 7 days duration after receiving chemotherapy to induce or maintain remission of acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS), and recipients of allogeneic stem cell transplantation

3 Secondary aims The outcome of each category of IMD will be determined depending upon whether or not antifungal therapy is given. – Survival at 6 months – The treatment outcome 12 weeks after starting antifungal therapy – Progression of IMD – Exploration of feasibility of adopting a diagnostic- driven approach

4 Steering Committee Catherine Cordonnier Manuel Cuenca-Estrella J Peter Donnelly (Principal Investigator) Raoul Herbrecht Chris Kibbler Conny Lass-Flörl Johan Maertens Marianne Paesmans

5 PIMDA Milestones Aug 2011 Study design finalised 5 June 2012 Enrolment opens 5 Dec 2012 Enrolment ends 5 June month follow-up ends End of June 2013 (est.)Primary analysis 43 participating centres 17 Countries

6 Participating centres Austria 3 sites Belgium 5 sites Croatia 2 sites Czech Republic 2 sites France 2 sites Germany 5 sites Hungary 1 site Israel 2 sites Italy 3 sites Netherlands 1 site Poland 1 site Portugal 1 site Russia 3 sites Slovakia 1 site Spain 4 sites Turkey 5 sites UK 2 sites

7 PIMDA enrolment Weeks No. of patients

8 Publications Congress abstract (primary endpoint) – TIMM Congress, October 2013 Primary publication (primary endpoint) – First draft for discussion, October 2013 – Authors, PIMDA Steering Committee on behalf of the PIMDA Study Group – Lead author, J Peter Donnelly Secondary publications (secondary endpoints) – Open to individual investigators to take the lead subject to approval by the Steering Committee

9 PIMDA Further information Further information Website:


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