Hematologic malignancies treated with allogeneic hematopoietic stem cell transplantation. (acute leukemias, myelodysplastic syndromes, lymphomas, and other malignant disorders for which allogeneic HSCT is indicated), Primary immunodeficiencies and other non‑malignant disorders treated with allogeneic hematopoietic stem cell transplantation. (severe combined immunodeficiency, congenital immune dysregulation syndromes, and other inherited conditions for which HSCT is the curative therapy)
Conditions
Brief summary
Occurrence of at least one bloodstream infection, confirmed by a positive blood culture, during the treatment period or up to 30 days after transplantation, whichever is longer.
Detailed description
Mortality endpoint family: Overall mortality at 12 months post‑transplant, Overall mortality at 100 days post‑transplant, Infection‑related mortality at 100 days post‑transplant, Infection‑related mortality at 12 months post‑transplant, Occurrence of neutropenic fever from transplantation until neutrophil engraftment, Occurrence of severe infection requiring intensive care or high‑dependency care during the treatment period or up to 30 days after transplantation, Occurrence of Clostridioides difficile infection within 3 months after transplantation, Total number of days of systemic antibacterial treatment during the treatment period or up to 30 days after transplantation, Occurrence of acute graft‑versus‑host disease grade III–IV within 100 days after transplantation
Interventions
DRUGLevonic 5 mg/ml infuusioneste
DRUGliuos
DRUGNatriumklorid Baxter Viaflo 9 mg/ml
DRUGinfuusioneste
DRUGLEVOFLOXACIN
DRUGPlacebo 9mm YA 80746
Sponsors
HUS-yhtymae
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of at least one bloodstream infection, confirmed by a positive blood culture, during the treatment period or up to 30 days after transplantation, whichever is longer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality endpoint family: Overall mortality at 12 months post‑transplant, Overall mortality at 100 days post‑transplant, Infection‑related mortality at 100 days post‑transplant, Infection‑related mortality at 12 months post‑transplant, Occurrence of neutropenic fever from transplantation until neutrophil engraftment, Occurrence of severe infection requiring intensive care or high‑dependency care during the treatment period or up to 30 days after transplantation, Occurrence of Clostridioides difficile infection within 3 months after transplantation, Total number of days of systemic antibacterial treatment during the treatment period or up to 30 days after transplantation, Occurrence of acute graft‑versus‑host disease grade III–IV within 100 days after transplantation | — |
Outcome results
None listed