Burn Patients Clinical Trial
— AMIKACINEOfficial title:
Amikacin Pharmacokinetic Profile in Plasma and Tissue After an Administration Using Impregnated Dressings in Burned Patient Population
The loss of skin barrier function after burn causes increased susceptibility to infections,
which are the leading cause of morbidity and mortality in burn patients. Topical antibiotics
are one part of the therapeutic arsenal available to treat these infections. Pseudomonas
aeruginosa and Staphylococcus aureus are the two major colonizing agents found in this
population of patients.
The use of dressings impregnated with amikacin is a common practice. Actually, there are no
available data on local and systemic effects with this antibiotic. The study of tissue and
plasma pharmacokinetics of amikacin is therefore very important to secure and optimize this
singular use of amikacin and improve the care of burn patients.
The objective of the study is to describe the plasma and tissue pharmacokinetics of amikacin
after dermal administration and impregnated dressing to estimate the pharmacokinetic
parameters and their variability in a burned population.
Secondary objectives are to assess on the one hand the relationship between the
effectiveness of treatment and the concentration of antibiotic at the site of tissue
infection, and on the other hand to assess the relationship between plasma concentration and
the toxicity found of this treatment. We would like also to note the efficacy of the
antibiotic treatment in terms of: need for repeat surgery (new skin graft), healing time and
hospital length of stay.
Blood samples and skin biopsies will be made for each patient to day 3 and day 7 after the
start of treatment.
The knowledge about the tissue concentrations obtained and a possible systemic absorption
will then provide additional safety data and optimize the conditions of use of these
dressings (dosage, frequency of administration) for effective treatment and safe.
| Status | Not yet recruiting |
| Enrollment | 75 |
| Est. completion date | January 2019 |
| Est. primary completion date | January 2019 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hôpitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Determination of amikacin concentration | Concentration of amikacin in nanograms per milliliter. Circulating amikacin will be quantified by chromatographic high-performance technology | 24 months | Yes |
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