NCT04434300

Subcutaneous Daptomycin in Healthy Volunteers (DAPTOSC)

Comparison of the Pharmacokinetic and the Safety of Daptomycin Administered Subcutaneously Compared to the Intravenous Route : a Cross-over Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Daptomycin	Compare the pharmacokinetic of subcutaneous (SC) and intravenous (IV) routes in the same patient.
DRUG	Daptomycin	Compare the pharmacokinetic of subcutaneous (SC) and intravenous (IV) routes in the same patient.

Timeline

• Start date: 2020-10-15
• Primary completion: 2021-01-15
• Completion: 2021-11-15
• First posted: 2020-06-16
• Last updated: 2026-04-14

Locations

1 site across 1 country: France