Aplastic Anemia, Bone Marrow Transplantation, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Conditions
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.
Interventions
DRUGPosaconazole
Sponsors
King's College Hospital NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult ≥ 18 years 2. Patients with aplastic anaemia, MDS or AML undergoing: IST; or Intensive chemotherapy such as induction chemotherapy; or RIC allogeneic HSCT 3. Able to swallow and retain orally administered medication
Exclusion criteria
1. Refusal or inability to consent 2. Autologous HSCT 3. Contraindicated medications 4. Current evidence of IFD diagnosis or treatment 5. Enrolled in another study requiring alternative antifungal prophylaxis or treatment 6. Women who are pregnant or lactating 7. Women who are unable to use and apply with effective contraception without interruption throughout the duration of study drug therapy and not willing to have further pregnancy tests during the course of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative incidence of IFD in all treatment groups (aplastic anaemia with IST, chemotherapy only, RIC allograft) | 24 weeks |
Countries
United Kingdom
Outcome results
None listed