King's Invasive Aspergillosis Study II

NCT ID: NCT02875743

Last Updated: 2020-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-07

Study Completion Date

2019-10-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Posaconazole

Group Type EXPERIMENTAL

Posaconazole

Intervention Type DRUG

Interventions

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Posaconazole

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College Hospital NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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King's College Hospital NHS Foundation Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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KIASII

Identifier Type: -

Identifier Source: org_study_id

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