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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
King's College Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aplastic Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
August 18, 2016
Last Updated
April 1, 2020
Sponsor
King's College Hospital NHS Trust
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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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