Working Group on Immunologic Markers for Diagnosis and Treatment Monitoring in Invasive Mold Infection

Investigators:
• Martin Hoenigl , MD, FECMM & Juergen Prattes, MD, Infectious Diseases, Medical University of Graz, Austria
• Agostinho Carvalho , PhD, FECMM, University of Minho, Braga, Portugal
• Toine Mercier, MD, Hematology, KU Leuven, Belgium
• Philipp Koehler , MD, Infectious Diseases/Hematology, University of Cologne, Germany
• Mihai Netea , PhD, & Frank van de Veerdonk , PhD, Immunology/Microbiology, UMC Radboud, Nijmegen, Netherlands
• Carol Garcia Vidal , MD & Celia Cardozo , MD, Infectious Diseases, Hospital Clinic de Barcelona, Barcelona, Spain
• Theresa Martin , MD, Microbiology, University Hospital Vall d’Hebron Barcelona, Spain
• Livio Pagano, MD, FECMM, President of the EORTC, Hematology, Catholic University of Sacred Heart, Rome, Italy
• Jean Pierre Gangneux , MD, FECMM, Microbiology, Centre Hospitalier Universitaire de Rennes, France
• Cornelia Lass Floerl , MD, FECMM, Microbiology, Innsbruck Medical University, Austria
• Dieter Buchheidt, MD, FECMM, Hematology, University Hospital of Mannheim, Germany

• The first big goal: Obtain funding and initiate an observational Multicenter study on Immunologic Markers in Blood (and maybe also BALF) for Diagnosis and Treatment Monitoring in probable/proven Invasive Mold Infection

Aims:
• Immunologic Markers for Treatment Monitoring (Aim 1): Primarily prospective sample collection
• Immunologic Markers for Diagnosis of Invasive Mold Infections (Aim 2): Primarily leveraging of existing ongoing cohort studies. Leuven (no antimold prophylaxis) &
Cologne (ALL patients)
• Duration of Prospective Study: 2 years
• AIM 1: N=50 cases (probable/proven IMI)
• AIM 2: N=33 cases (probable/proven IMI) & N=66 controls (no IMI)
• Patients:
Underlying Hematological Malignancies (with and without antimould prophylaxis, Neutropenic plus GvHD,
50% negative serum GM; for Aim 2 also ALL because no mold active AF prophylaxis)
• Sampling:
• AIM 1: Serial Blood Draws; Blood Draws starting on the day of diagnosis, then daily for first 3 days, then every 2
days for another 6 days, then every 3 days up to day 15 PLUS BALF if available from routine; average 8
samples/ patient (=400 samples)
• AIM 2: Serial serum samples 2 weeks before until 2 weeks after diagnosis (plus BALF samples if available);
average 5 samples per patient (=495 samples)
• Storage: Plasma and BALF stored at −70 C at each participating center and then shipped in batch to Nijmegen for
retrospective cytokine measurement
• Central Laboratory: Nijmegen ( Netea and Van de Veerdonk