invasive fungal infection pulmonary fungal infection
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Age 18 yrs and older • Inclusion within 1 day before start of cytoreductive treatment or remission induction chemotherapy for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) OR for myeloablative conditioning of allogeneic stem cell transplantation (HSCT) including FLAMSA conditioning • Expected absolute neutrophil count of
Exclusion criteria
Exclusion criteria: • Pregnant female subjects • Current or previous history of primary or metastatic lung malignancy • Treatment for pulmonary fungal infection in preceding 3 months • Inflammatory bowel disease or any inflammatory bowel condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of possible or probable PFI using this diagnostic protocol 2. Rate and diversity of pathological imaging findings suggestive of PFI 3. Compare diagnostic performance of standardized conventional radiological assessment (IPARADS) versus computer aided assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| (a) Describe imaging features that are not associated with PFI: number of lesions/events (b) Describe the development and reduction of PFI features during aplasia and neutropenia recovery. (c) Exploration of the imaging kinetics and response kinetics during fungal infections with computer aided analysis of target lesions (d) Describe treatment duration and outcome following CT-guided response evaluation | — |
Countries
Netherlands