King's Invasive Aspergillosis Study II

King's College Hospital NHS Trust120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

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

Interventions

PosaconazoleDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

King's College Hospital NHS Foundation Trust

London, United Kingdom

Outcomes

Primary Outcomes

Cumulative incidence of IFD in all treatment groups (aplastic anaemia with IST, chemotherapy only, RIC allograft)

Time frame: 24 weeks

Data from ClinicalTrials.gov

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