Subcutaneous Daptomycin in Healthy Volunteers (DAPTOSC)

Antibiotics Clinical Trial

— DAPTOSC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04434300
• Other study ID #: 2019-004884-32
• Status: Completed
• Phase: Phase 1
• Start date: October 15, 2020
• Est. completion date: November 15, 2021

Study information

• Verified date: July 2021
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Antibiotics
• Daptomycin
• Subcutaneous Injection

Intervention

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

Locations

Country	Name	City	State
France	CHU Caen	Caen	Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	daptomycin dosage after intravenous route	measurement of daptomycin blood concentration after intravenous route	before injection
Primary	daptomycin dosage after intravenous route	measurement of daptomycin blood concentration after intravenous route	30 minutes after injection
Primary	daptomycin dosage after intravenous route	measurement of daptomycin blood concentration after intravenous route	1 hours after injection
Primary	daptomycin dosage after intravenous route	measurement of daptomycin blood concentration after intravenous route	1,50 hours after injection
Primary	daptomycin dosage after intravenous route	measurement of daptomycin blood concentration after intravenous route	2 hours after injection
Primary	daptomycin dosage after intravenous route	measurement of daptomycin blood concentration after intravenous route	3 hours after injection
Primary	daptomycin dosage after intravenous route	measurement of daptomycin blood concentration after intravenous route	4 hours after injection
Primary	daptomycin dosage after intravenous route	measurement of daptomycin blood concentration after intravenous route	8 hours after injection
Primary	daptomycin dosage after intravenous route	measurement of daptomycin blood concentration after intravenous route	10 hours after injection
Primary	daptomycin dosage after intravenous route	measurement of daptomycin blood concentration after intravenous route	24 hours after injection
Primary	daptomycin dosage after subcutaneous route	measurement of daptomycin blood concentration after subcutaneous route	before injection
Primary	daptomycin dosage after subcutaneous route	measurement of daptomycin blood concentration after subcutaneous route	30 minutes after injection
Primary	daptomycin dosage after subcutaneous route	measurement of daptomycin blood concentration after subcutaneous route	1 hours after injection
Primary	daptomycin dosage after subcutaneous route	measurement of daptomycin blood concentration after subcutaneous route	1.50 hours after injection
Primary	daptomycin dosage after subcutaneous route	measurement of daptomycin blood concentration after subcutaneous route	2 hours after injection
Primary	daptomycin dosage after subcutaneous route	measurement of daptomycin blood concentration after subcutaneous route	3 hours after injection
Primary	daptomycin dosage after subcutaneous route	measurement of daptomycin blood concentration after subcutaneous route	4 hours after injection
Primary	daptomycin dosage after subcutaneous route	measurement of daptomycin blood concentration after subcutaneous route	8 hours after injection
Primary	daptomycin dosage after subcutaneous route	measurement of daptomycin blood concentration after subcutaneous route	10 hours after injection
Primary	daptomycin dosage after subcutaneous route	measurement of daptomycin blood concentration after subcutaneous route	24 hours after injection
Secondary	Local adverse events	Occurrence of local adverse events (pain, erythema, edema, necrosis)	within the first 24hours after injection
Secondary	Local adverse events	Occurrence of local adverse events (pain, erythema, edema, necrosis)	3 days after the infusion
Secondary	Local adverse events	Occurrence of local adverse events (pain, erythema, edema, necrosis)	7 days after the infusion
Secondary	Systemic adverse events	Occurrence of systemic adverse events	within the first 24hours after injection
Secondary	Systemic adverse events	Occurrence of systemic adverse events	3 days after the infusion
Secondary	Systemic adverse events	Occurrence of systemic adverse events	7 days after the infusion