King's Invasive Aspergillosis Study II (KIASII)
Research type
Research Study
Full title
Incidence of Invasive Fungal Disease in Patients receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole Prophylaxis
IRAS ID
192048
Contact name
Antonio Pagliuca
Contact email
Sponsor organisation
King's College Hospital NHS Foundation Trust
Eudract number
2016-001223-31
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This study aims to assess the impact of using tablet posaconazole (an anti-fungal agent) on the incidence of invasive fungal disease (IFD) in patients with aplastic anaemia, Myelodysplasia (MDS) or Acute Myeloid Leukaemia (AML) who are undergoing immuosuppressive therapy, intensive chemotherapy or RIC allogeneic haematopoietic stem cell transplant (HSCT).
The study will be open to recruitment for 12 to 24 months. Participants enrolled on the study will be treated according to standard care with an additional CT scan at study entry (if one has not been performed within two weeks of study entry) and additional blood tests taken at the same time as routine samples. Clinical, laboratory and radiological information taken as part of normal care will be prospectively collected for this study. Each patient will be followed up for at least 16 weeks from the last admission for chemotherapy, immunosuppressive therapy or transplant with no ongoing complications such as GVHD.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
16/YH/0370
Date of REC Opinion
11 Oct 2016
REC opinion
Further Information Favourable Opinion