King's Invasive Aspergillosis Study II
Primary Purpose
Aplastic Anemia, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Posaconazole
Sponsored by
About this trial
This is an interventional prevention trial for Aplastic Anemia
Eligibility Criteria
INCLUSION CRITERIA
- Adult ≥ 18 years
- Patients with aplastic anaemia, MDS or AML undergoing: IST; or Intensive chemotherapy such as induction chemotherapy; or RIC allogeneic HSCT
- Able to swallow and retain orally administered medication
EXCLUSION CRITERIA
- Refusal or inability to consent
- Autologous HSCT
- Contraindicated medications
- Current evidence of IFD diagnosis or treatment
- Enrolled in another study requiring alternative antifungal prophylaxis or treatment
- Women who are pregnant or lactating
- 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
Sites / Locations
- King's College Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Posaconazole
Arm Description
Outcomes
Primary Outcome Measures
Cumulative incidence of IFD in all treatment groups (aplastic anaemia with IST, chemotherapy only, RIC allograft)
Secondary Outcome Measures
Full Information
NCT ID
NCT02875743
First Posted
August 18, 2016
Last Updated
April 1, 2020
Sponsor
King's College Hospital NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02875743
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 7, 2016 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aplastic Anemia, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Bone Marrow Transplantation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Posaconazole
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Posaconazole
Primary Outcome Measure Information:
Title
Cumulative incidence of IFD in all treatment groups (aplastic anaemia with IST, chemotherapy only, RIC allograft)
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA
Adult ≥ 18 years
Patients with aplastic anaemia, MDS or AML undergoing: IST; or Intensive chemotherapy such as induction chemotherapy; or RIC allogeneic HSCT
Able to swallow and retain orally administered medication
EXCLUSION CRITERIA
Refusal or inability to consent
Autologous HSCT
Contraindicated medications
Current evidence of IFD diagnosis or treatment
Enrolled in another study requiring alternative antifungal prophylaxis or treatment
Women who are pregnant or lactating
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
Facility Information:
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
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King's Invasive Aspergillosis Study II
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