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 transcript:

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)

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

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

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

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

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

PIMDA enrolment Weeks No. of patients

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

PIMDA Further information Further information Website: