A Phase 4 interventional study of Treatment with Amikacin in Burn Patients, sponsored by Assistance Publique Hopitaux De Marseille. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by Assistance Publique Hopitaux De Marseille · Phase 4, Interventional, and Treatment
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.
Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 146 are open to participants now.
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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
Dressing impregnated by administration of amikacin
Drug: Treatment with Amikacin
Aminoglycosides. Blood sampling for pharmacokinetic evaluation
Determination of amikacin concentration
Concentration of amikacin in nanograms per milliliter. Circulating amikacin will be quantified by chromatographic high-performance technology
Time frame: 24 months
Plan to share: No
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This study is terminated, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Assistance Publique Hopitaux De Marseille