Subcutaneous Daptomycin in Healthy Volunteers (DAPTOSC)

NCT ID: NCT04434300

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2021-11-15

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.

Conditions

Antibiotics; Subcutaneous Injection; Daptomycin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dapto SC-IV

First stage :

• Subcutaneous injection of daptomycin 10mg/kg
• Subcutaneous injection of placebo (physiological serum)

Second stage :

• Intravenous injection of daptomycin 10mg/kg

Group Type: OTHER

Daptomycin

Intervention Type: DRUG

Compare the pharmacokinetic of subcutaneous (SC) and intravenous (IV) routes in the same patient.

Dapto IV-SC

First stage :

• Intravenous injection of daptomycin 10mg/kg

Second stage :

• Subcutaneous injection of daptomycin 10mg/kg
• Subcutaneous injection of placebo (physiological serum)

Group Type: OTHER

Daptomycin

Intervention Type: DRUG

Compare the pharmacokinetic of subcutaneous (SC) and intravenous (IV) routes in the same patient.

Interventions

Daptomycin

Compare the pharmacokinetic of subcutaneous (SC) and intravenous (IV) routes in the same patient.

Intervention Type: DRUG

Daptomycin

Compare the pharmacokinetic of subcutaneous (SC) and intravenous (IV) routes in the same patient.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Caen

Caen, Normandy, France

Countries

France

References

Maurille C, Baldolli A, Creveuil C, Parienti JJ, Michon J, Peyro-Saint-Paul L, Brucato S, Dargere S, Comets E, Verdier MC, Verdon R. Pharmacokinetics and safety of daptomycin administered subcutaneously in healthy volunteers: a single-blinded randomized crossover trial. J Antimicrob Chemother. 2024 Nov 4;79(11):3016-3022. doi: 10.1093/jac/dkae324.

Reference Type: DERIVED

PMID: 39271104 (View on PubMed)

Other Identifiers

2019-004884-32

Identifier Type: -

Identifier Source: org_study_id