Status:
COMPLETED
Subcutaneous Daptomycin in Healthy Volunteers (DAPTOSC)
Lead Sponsor:
University Hospital, Caen
Conditions:
Antibiotics
Subcutaneous Injection
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 t...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04434300
Start Date
October 15 2020
End Date
November 15 2021
Last Update
February 1 2022
Active Locations (1)
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1
CHU Caen
Caen, Normandy, France, 14000