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European Prospective Invasive Mould Disease Audit: Rate and Outcomes of Invasive Mould Disease in At-Risk Patients

This observational study aims to determine the rate of occurrence of invasive mould disease (IMD) and treatment outcomes in at-risk patients receiving chemotherapy for acute myeloid leukemia or myelodysplastic syndrome, and recipients of allogeneic stem cell transplantation. The study will explore the feasibility of adopting a diagnostic-driven approach and provide important insights into the effectiveness of antifungal therapy.

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European Prospective Invasive Mould Disease Audit: Rate and Outcomes of Invasive Mould Disease in At-Risk Patients

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  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 2013 6-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 No. of patients Weeks

  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: www.pimda.eu

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