King’s Invasive Aspergillosis Study II

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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

, ,

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