Subcutaneous Daptomycin in Healthy Volunteers (DAPTOSC)

Sponsor

University Hospital, Caen (Other)

Overall Status

Completed

CT.gov ID

NCT04434300

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Antibiotics Subcutaneous Injection Daptomycin	Drug: Daptomycin Drug: Daptomycin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 15, 2020

Actual Primary Completion Date :

Jan 15, 2021

Actual Study Completion Date :

Nov 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: 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	Drug: Daptomycin Compare the pharmacokinetic of subcutaneous (SC) and intravenous (IV) routes in the same patient.
Other: 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)	Drug: Daptomycin Compare the pharmacokinetic of subcutaneous (SC) and intravenous (IV) routes in the same patient.

Arm

Intervention/Treatment

Other: 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

Drug: Daptomycin

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

Other: 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)

Drug: Daptomycin

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

Outcome Measures

Primary Outcome Measures

daptomycin dosage after intravenous route [before injection]
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route [30 minutes after injection]
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route [1 hours after injection]
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route [1,50 hours after injection]
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route [2 hours after injection]
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route [3 hours after injection]
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route [4 hours after injection]
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route [8 hours after injection]
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route [10 hours after injection]
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route [24 hours after injection]
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after subcutaneous route [before injection]
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route [30 minutes after injection]
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route [1 hours after injection]
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route [1.50 hours after injection]
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route [2 hours after injection]
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route [3 hours after injection]
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route [4 hours after injection]
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route [8 hours after injection]
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route [10 hours after injection]
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route [24 hours after injection]
measurement of daptomycin blood concentration after subcutaneous route

Secondary Outcome Measures

Local adverse events [within the first 24hours after injection]
Occurrence of local adverse events (pain, erythema, edema, necrosis)
Local adverse events [3 days after the infusion]
Occurrence of local adverse events (pain, erythema, edema, necrosis)
Local adverse events [7 days after the infusion]
Occurrence of local adverse events (pain, erythema, edema, necrosis)
Systemic adverse events [within the first 24hours after injection]
Occurrence of systemic adverse events
Systemic adverse events [3 days after the infusion]
Occurrence of systemic adverse events
Systemic adverse events [7 days after the infusion]
Occurrence of systemic adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Caen	Caen	Normandie	France	14000

Sponsors and Collaborators

University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT04434300

Other Study ID Numbers:

2019-004884-32

First Posted:

Jun 16, 2020

Last Update Posted:

Feb 1, 2022

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Daptomycin

Study Results

No Results Posted as of Feb 1, 2022