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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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29 August 2016 |
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Main ID: |
NCT02872272 |
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Date of registration:
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16/08/2016 |
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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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Amikacin Pharmacokinetic Profile in Plasma and Tissue After an Administration Using Impregnated Dressings in Burned Patient Population
AMIKACINE |
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Scientific title:
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Amikacin Pharmacokinetic Profile in Plasma and Tissue After an Administration Using Impregnated Dressings in Burned Patient Population |
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Date of first enrolment:
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January 2017 |
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Target sample size:
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75 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02872272 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Sandrine WIRAMUS, PH |
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Address:
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Telephone:
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04.91.38.38.55 |
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Email:
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sandrine.wiramus@ap-hm.fr |
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Affiliation:
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Name:
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Sandrine WIRAMUS, PH |
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Address:
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Telephone:
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04.91.38.38.55 |
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Email:
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sandrine.wiramus@ap-hm.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Skin infection of burn (whatever the surface, depth or location) supported by
percutaneous administration of amikacin Age greater than 18 years Patient can be under
guardianship or trusteeship Patient may present with cognitive impairment Patients
receiving social coverage Patient who understood the objectives of the study, agreeing to
participate in the study and who signed informed consent (or for which a trustee or
guardian signed an informed consent if necessary) Patient mastering the French language
Exclusion Criteria:
minor patient or pregnant or lactating deprived of liberty patient Patient does not have
insurance coverage Patient does not agreeing to participate in the study Patient allergic
to amikacin or other antibiotic aminoglycosides
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Burn Patients
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Intervention(s)
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Drug: Treatment with Amikacin
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Primary Outcome(s)
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Determination of amikacin concentration
[Time Frame: 24 months]
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Secondary ID(s)
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2015-09
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2015-003972-64
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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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