Antibiotics, Daptomycin, Subcutaneous Injection
Conditions
Brief summary
Background: Multidrug-resistant bacteria are a major public health problem worldwide, notably due to excess mortality and an increase in the length of hospital stay. Antibiotics that can be used to treat these infections are limited. Daptomycin is one of the most widely used antibiotics for the treatment of infections with gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA). However, it is only administered intravenously (IV). It is therefore interesting to find new routes of administration in order to widen the possibilities of using daptomycin, especially in people who have difficulties with the venous approach. Methods/design: In a randomized, single blinded, crossover, noninferiority study in the CHU of Caen, the investigators aim to demonstrate the pharmacokinetic bioequivalence between the subcutaneous and the intravenous route of daptomycin in healthy volunteers. They will conclude the bioequivalence if the confidence interval of the area under the curve obtained is entirely within the interval \[80% - 125%\]. Discussion: This clinical trial could, if bioequivalence is demonstrated, lead to the completion of a clinical trial in infected patients in order to assess the efficacy and safety of daptomycin by the subcutaneous route.
Interventions
DRUGDaptomycin
Compare the pharmacokinetic of subcutaneous (SC) and intravenous (IV) routes in the same patient.
Sponsors
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Subcutaneous administration of daptomycin and placebo will be done blind to the participant. Given the yellow coloration of daptomycin, a masking of the pockets of daptomycin and NaCl will be carried out with a pocket cover and an opaque tube will be used for the administration
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteer from 18 to 65 years old * Subject determined in good health by a doctor * Signature of free and informed consent * Affiliated to the French healthcare insurance * Fluent in French
Exclusion criteria
* Active bacterial or viral infection * Immunocompromised * Body mass index \<20 or\> 30 kg / m2 * Kidney failure with glomerular filtration rate \<90ml / min / m2 calculated according to the CKD-EPI method * Known or suspected liver disease * Pregnant or lactating woman * Guardianship or curators * Any situation that could interfere with the self / hetero assessment of pain (dementia, psychiatric disorders, for example) * Concomitant intake of myotoxic drugs (statins, fibrates, ciclosporin, for example) * Allergy or known side effects to daptomycin * Dermatological pathologies which may interfere with the subcutaneous injection (eczema, psoriasis, etc.) * Localized tattoo or piercing on the abdomen which may interfere with the subcutaneous injection or the evaluation of possible local effects of the injection * Parenteral exposure to daptomycin in the previous 30 days * The inclusion of the subject in another interventional research protocol (during the present study and in the 3 months before inclusion).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| daptomycin dosage after intravenous route | before injection | measurement of daptomycin blood concentration after intravenous route |
| daptomycin dosage after subcutaneous route | before injection | measurement of daptomycin blood concentration after subcutaneous route |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local adverse events | within the first 24hours after injection | Occurrence of local adverse events (pain, erythema, edema, necrosis) |
| Systemic adverse events | within the first 24hours after injection | Occurrence of systemic adverse events |
Countries
France
Outcome results
None listed