King's Invasive Aspergillosis Study II

Phase 4

Completed

• Conditions: Aplastic Anemia; Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Bone Marrow Transplantation
• Interventions: Drug: Posaconazole

• Registration Number: NCT02875743
• Lead Sponsor: King's College Hospital NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-18
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-23
• Study Start: 2016-12-07
• Primary Completion: 2018-10-31
• Study Completion: 2019-10-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Posaconazole	Posaconazole	-

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of IFD in all treatment groups (aplastic anaemia with IST, chemotherapy only, RIC allograft)	24 weeks

Trial Locations

Locations (1)

King's College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom