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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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16 March 2015 |
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Main ID: |
NCT02372357 |
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Date of registration:
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06/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area
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Scientific title:
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A New Dosing Regimen for Posaconazole Prophylaxis in Children Based in Body Surface Area |
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Date of first enrolment:
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February 2012 |
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Target sample size:
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14 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02372357 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Belgium
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Romania
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Contacts
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Name:
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Kim Vanstraelen, PharmD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Catholic University Leuven, Leuven, Belgium |
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Name:
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Anca Colita, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institutul Clinic Fundeni, Bucarest, Romania |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 2-13 years of age
- hematological malignancy
- need for antifungal prophylaxis because of neutropenia caused by chemotherapy and/or
hematopoietic stem cell transplantation.
Exclusion Criteria:
- <2 years of age
- > 13 years of age
Age minimum:
2 Years
Age maximum:
13 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hematological Malignancy
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Intervention(s)
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Drug: Posaconazole prophylaxis 120 mg/m² tid
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Procedure: Blood sampling
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Primary Outcome(s)
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pharmacokinetic parameters of posaconazole
[Time Frame: One day at steady state posaconazole treatment]
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Secondary Outcome(s)
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Efficacy: patients are monitored for breakthrough infections according the the European Organisation for Research and Treatment of Cancer- Mycoses Study Group (EORTC-MSG) criteria.
[Time Frame: patients will be followed for the duration of hospital stay, an expected average of 3-4 weeks]
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Safety of posaconazole, focussing on nausea, vomiting and liver function abnormalities (according to the Common Terminology Criteria for Adverse Events (CTCAE classification).
[Time Frame: patients will be followed for the duration of hospital stay, an expected average of 3-4 weeks]
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Secondary ID(s)
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2841/20 Feb 2012
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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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