King's Invasive Aspergillosis Study II

Myelodysplastic Syndromes Clinical Trial

Official title:

Incidence of Invasive Fungal Disease in Patients Receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole Prophylaxis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875743
• Other study ID #: KIASII
• Status: Completed
• Phase: Phase 4
• Start date: December 7, 2016
• Est. completion date: October 31, 2019

Study information

• Verified date: April 2020
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Aplastic
• Aplastic Anemia
• Bone Marrow Transplantation
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes

Intervention

Drug:
• Posaconazole

Locations

Country	Name	City	State
United Kingdom	King's College Hospital NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of IFD in all treatment groups (aplastic anaemia with IST, chemotherapy only, RIC allograft)		24 weeks