Study Results
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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COMPLETED
PHASE4
120 participants
INTERVENTIONAL
2016-12-07
2019-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Posaconazole
Posaconazole
Interventions
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Posaconazole
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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King's College Hospital NHS Trust
OTHER
Responsible Party
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Locations
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King's College Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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Other Identifiers
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KIASII
Identifier Type: -
Identifier Source: org_study_id
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