Subcutaneous Daptomycin in Healthy Volunteers (DAPTOSC)

Caen University Hospital

Status and phase: Completed; Phase 1

Conditions: Daptomycin; Subcutaneous Injection; Antibiotics

Treatments: Drug: Daptomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT04434300

2019-004884-32

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

12 participants in 2 patient groups

Dapto SC-IV

Other group

Description:

First stage : * Subcutaneous injection of daptomycin 10mg/kg * Subcutaneous injection of placebo (physiological serum) Second stage : - Intravenous injection of daptomycin 10mg/kg

Treatment:

Drug: Daptomycin

Drug: Daptomycin

Dapto IV-SC

Other group

Description:

First stage : - Intravenous injection of daptomycin 10mg/kg Second stage : * Subcutaneous injection of daptomycin 10mg/kg * Subcutaneous injection of placebo (physiological serum)

Treatment:

Drug: Daptomycin

Drug: Daptomycin