Brief Title
King's Invasive Aspergillosis Study II
Official Title
Incidence of Invasive Fungal Disease in Patients Receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole Prophylaxis
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Cumulative incidence of IFD in all treatment groups (aplastic anaemia with IST, chemotherapy only, RIC allograft)
Condition
Aplastic Anemia
Intervention
Posaconazole
Study Arms / Comparison Groups
Posaconazole
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
120
Start Date
December 7, 2016
Completion Date
October 31, 2019
Primary Completion Date
October 31, 2018
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT02875743
Organization ID
KIASII
Responsible Party
Sponsor
Study Sponsor
King's College Hospital NHS Trust
Study Sponsor
, ,
Verification Date
April 2020