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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02875743 |
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Date of registration:
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18/08/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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King's Invasive Aspergillosis Study II
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Scientific title:
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Incidence of Invasive Fungal Disease in Patients Receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole Prophylaxis |
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Date of first enrolment:
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December 7, 2016 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02875743 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bone Marrow Transplantation
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Leukemia, Myeloid, Acute
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Aplastic Anemia
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Myelodysplastic Syndromes
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Intervention(s)
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Drug: Posaconazole
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Primary Outcome(s)
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Cumulative incidence of IFD in all treatment groups (aplastic anaemia with IST, chemotherapy only, RIC allograft)
[Time Frame: 24 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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