Burn PatientsPhase 4AMIKACINENCT02872272
Amikacin Pharmacokinetic Profile in Plasma and Tissue After an Administration Using Impregnated Dressings in Burned Patient Population
A Phase 4 study testing Treatment with Amikacin in people with Burn Patients, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Patients
- What is being tested?
- Treatment with Amikacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2020to 9 Jul 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Burn Patients
- Being tested
- Treatment with Amikacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with AmikacinDrug
Aminoglycosides. Blood sampling for pharmacokinetic evaluation
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Amikacin | Experimental | Dressing impregnated by administration of amikacin Receives: Drug: Treatment with Amikacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of amikacin concentration
Concentration of amikacin in nanograms per milliliter. Circulating amikacin will be quantified by chromatographic high-performance technology
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start6 Jan 2020
- Primary completion9 Jul 2021
- Study completion9 Jul 2021
Why it stopped: not enough participants to include
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872272
- Sponsor's protocol ID
- 2015-09
- Other IDs
- 2015-003972-64, 2015
- Acronym
- AMIKACINE
- Status last verified
- Jun 2024
- First submitted
- 16 Aug 2016
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amikacin Pharmacokinetic Profile in Plasma and Tissue After an Administration Using Impregnated Dressings in Burned Patient Population
- ClinicalTrials.gov ID
- NCT02872272
- Acronym / sponsor ID
- AMIKACINE / 2015-09
- Conditions
- Burn Patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough participants to include
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Amikacin | Experimental | Drug: Treatment with AmikacinDressing impregnated by administration of amikacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with AmikacinAminoglycosides. Blood sampling for pharmacokinetic evaluation | Drug | Treatment with Amikacin |
Primary outcome
Determination of amikacin concentration
Time frame: 24 months
Concentration of amikacin in nanograms per milliliter. Circulating amikacin will be quantified by chromatographic high-performance technology
Results and safety
The study was stopped early (reason given: not enough participants to include). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Treatment with Amikacin in people with Burn Patients, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: not enough participants to include). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of amikacin concentration (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.