Status:
UNKNOWN
Breakthrough Invasive Mold Infections Under Posaconazole Prophylaxis (BIMI)
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Conditions:
Invasive Mold Infections
Breakthrough Invasive Mold Infections
Eligibility:
All Genders
18+ years
Brief Summary
Invasive mold infections (IMI) mainly affect patients with hematologic malignancies receiving intensive chemotherapy or after hematopoietic stem cell transplantation (HSCT). Prolonged neutropenia afte...
Eligibility Criteria
Inclusion
- Cases:
- Adult (≥ 18 years old) patients with a hematologic malignancy receiving posaconazole prophylaxis (oral tablets or IV administration) for:
- i) Induction, consolidation or re-induction chemotherapy for acute leukemia or myelodysplastic syndrome (i.e. expected duration of neutropenia post-chemotherapy of ≥ 10 days)
- OR
- ii) Allogeneic hematopoietic stem cell transplant recipients during the post-transplantation phase (100-day post-transplantation) or later in case of intensified immunosuppression for moderate to severe graft vs host disease (GVHD).
- AND
- iii) Being diagnosed with proven or probable bIMI according to the EORTC-MSG classification (10) while on continuous posaconazole prophylaxis for at least 7 days.
- Controls:
- For each bIMI case, we will include 2 control cases fulfilling the following criteria:
- i) Receiving continuous posaconazole prophylaxis for at least 7 days
- ii) No diagnosis of proven, probable or possible IMI according to EORTC-MSG classification (10) during the entire hospital stay.
- And matched to bIMI cases according to the following criteria:
- iii) Hospitalization in the same ward within the same year (+/- 12 months interval)
- iv) Same underlying condition related to hematologc cancer: a) HSCT within 100 days post-engraftment, b) HSCT \> 100 days post-engraftment with intensified immunosuppressive regimen for severe GVHD, c) induction chemotherapy for acute myeloid or lymphoid leukemia, or myelodysplastic syndrome, d) other hematologic disorders (e.g. aplastic anemia) with prolonged neutropenia and/or immunosuppressive regimen.
Exclusion
- Patients with a diagnosis of possible IMI according to the EORTC-MSG classification.
- Patients with a positive fungal biomarker in serum (e.g. galactomannan or beta-glucan) in the absence of clinical or radiological criteria of IMI according to the EORTC-MSG classification.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04720144
Start Date
October 1 2020
End Date
September 30 2022
Last Update
February 9 2021
Active Locations (8)
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1
Medical University of Innsbruck
Innsbruck, Austria
2
University Hospital Cologne
Cologne, Germany
3
Universitätsspital Basel
Basel, Switzerland
4
Inselspital Bern
Bern, Switzerland