Plasma and tissue pharmacokinetics of amikacin administrated by dressing impregnated in burns patients

Phase 1

• Conditions: burns patients; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-003972-64-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-11
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Age minimal 18 years old.
male or female
Burn skin infection supported by percutaneous administration of amikacin. Presence of positive local signs of bacterial cutaneous infection meeting the criteria as defined by the French Society of Brulology (SFB):
Presence of a local or locoregional inflammatory reaction
and or
o an unfavorable and unexpected local evolution
at the burns: presence of pus, fast debridement, appearance of black spots (necrosis or haemorrhage), unexplained conversion of a superficial lesion to a deep lesion (> 48h)
at the level of engraftment: presence of pus, unexplained healing delay, pressure ulcer
at the level of the grafts: presence of pus, lysis of the grafts, necrosis of the fat located under the graft
at the level of healed areas: impetigo, lysis of healed areas.
Presence of a local or locoregional inflammatory reaction
and or an unfavorable and unexpected local evolution
At the level burns: presence of pus, fast debridement, appearance of black spots (necrosis or haemorrhage), unexplained conversion of a superficial lesion to a deep lesion (> 48h)
at the level of engraftment: presence of pus, unexplained healing delay, pressure ulcer
at the level of the grafts: presence of pus, lysis of the grafts, necrosis of the fat located under the graft
at the level of healed areas: impetigo, lysis of healed areas.
subject benefiting from social security
Subject agreeing to participate in the study and having signed an informed consent
Subject mastering the French language.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

Minor subject or pregnant or breastfeeding woman
Subject deprived of liberty
Subject under guardianship or guardianship
Subject does not have social security
Subject not accepting to participate in the study
subject having
Allergy to amikacin or other aminoglycoside antibiotic
Myasthenia gravis
Subject withdrawing consent during the study
Patients receiving intravenous aminoglycoside during local treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified