King's Invasive Aspergillosis Study II

King's College Hospital NHS Trust

Status and phase: Completed; Phase 4

Conditions: Leukemia, Myeloid, Acute; Aplastic Anemia; Myelodysplastic Syndromes; Bone Marrow Transplantation

Treatments: Drug: Posaconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02875743

KIASII

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Posaconazole

Experimental group

Treatment:

Drug: Posaconazole