NCT02875743
Completed
Phase 4
Incidence of Invasive Fungal Disease in Patients Receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole Prophylaxis
King's College Hospital NHS Trust1 site in 1 country120 target enrollmentDecember 7, 2016
ConditionsAplastic AnemiaLeukemia, Myeloid, AcuteMyelodysplastic SyndromesBone Marrow Transplantation
InterventionsPosaconazole
DrugsPosaconazole
Overview
- Phase
- Phase 4
- Intervention
- Posaconazole
- Conditions
- Aplastic Anemia
- Sponsor
- King's College Hospital NHS Trust
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Cumulative incidence of IFD in all treatment groups (aplastic anaemia with IST, chemotherapy only, RIC allograft)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Invasive fungal disease (IFD) is an important cause of mortality and morbidity in patients undergoing intensive chemotherapy or transplantation.
This current study aims to assess the impact of prophylactically using the broad-spectrum anti-fungal agent posaconazole on the incidence of IFD in high risk patients with aplastic anaemia and those undergoing intensive chemotherapy, for example for acute myeloid leukaemia, and allogeneic stem cell transplantation.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Posaconazole
Intervention: Posaconazole
Outcomes
Primary Outcomes
Cumulative incidence of IFD in all treatment groups (aplastic anaemia with IST, chemotherapy only, RIC allograft)
Time Frame: 24 weeks
Study Sites (1)
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