Skip to main content
OpenTrials
Completed

NCT Number: NCT04434300

Subcutaneous Daptomycin in Healthy Volunteers (DAPTOSC)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Antibiotics Daptomycin Subcutaneous Injection

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU Caen

Caen, Normandy, 14000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

daptomycin

Drug

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

Primary outcomes

  1. daptomycin dosage after intravenous route

    Time frame: before injection

    measurement of daptomycin blood concentration after intravenous route

  2. daptomycin dosage after intravenous route

    Time frame: 30 minutes after injection

    measurement of daptomycin blood concentration after intravenous route

  3. daptomycin dosage after intravenous route

    Time frame: 1 hours after injection

    measurement of daptomycin blood concentration after intravenous route

  4. daptomycin dosage after intravenous route

    Time frame: 1,50 hours after injection

    measurement of daptomycin blood concentration after intravenous route

  5. daptomycin dosage after intravenous route

    Time frame: 2 hours after injection

    measurement of daptomycin blood concentration after intravenous route

  6. daptomycin dosage after intravenous route

    Time frame: 3 hours after injection

    measurement of daptomycin blood concentration after intravenous route

  7. daptomycin dosage after intravenous route

    Time frame: 4 hours after injection

    measurement of daptomycin blood concentration after intravenous route

  8. daptomycin dosage after intravenous route

    Time frame: 8 hours after injection

    measurement of daptomycin blood concentration after intravenous route

  9. daptomycin dosage after intravenous route

    Time frame: 10 hours after injection

    measurement of daptomycin blood concentration after intravenous route

  10. daptomycin dosage after intravenous route

    Time frame: 24 hours after injection

    measurement of daptomycin blood concentration after intravenous route

  11. daptomycin dosage after subcutaneous route

    Time frame: before injection

    measurement of daptomycin blood concentration after subcutaneous route

  12. daptomycin dosage after subcutaneous route

    Time frame: 30 minutes after injection

    measurement of daptomycin blood concentration after subcutaneous route

  13. daptomycin dosage after subcutaneous route

    Time frame: 1 hours after injection

    measurement of daptomycin blood concentration after subcutaneous route

  14. daptomycin dosage after subcutaneous route

    Time frame: 1.50 hours after injection

    measurement of daptomycin blood concentration after subcutaneous route

  15. daptomycin dosage after subcutaneous route

    Time frame: 2 hours after injection

    measurement of daptomycin blood concentration after subcutaneous route

  16. daptomycin dosage after subcutaneous route

    Time frame: 3 hours after injection

    measurement of daptomycin blood concentration after subcutaneous route

  17. daptomycin dosage after subcutaneous route

    Time frame: 4 hours after injection

    measurement of daptomycin blood concentration after subcutaneous route

  18. daptomycin dosage after subcutaneous route

    Time frame: 8 hours after injection

    measurement of daptomycin blood concentration after subcutaneous route

  19. daptomycin dosage after subcutaneous route

    Time frame: 10 hours after injection

    measurement of daptomycin blood concentration after subcutaneous route

  20. daptomycin dosage after subcutaneous route

    Time frame: 24 hours after injection

    measurement of daptomycin blood concentration after subcutaneous route

Secondary outcomes

  1. Local adverse events

    Time frame: within the first 24hours after injection

    Occurrence of local adverse events (pain, erythema, edema, necrosis)

  2. Local adverse events

    Time frame: 3 days after the infusion

    Occurrence of local adverse events (pain, erythema, edema, necrosis)

  3. Local adverse events

    Time frame: 7 days after the infusion

    Occurrence of local adverse events (pain, erythema, edema, necrosis)

  4. Systemic adverse events

    Time frame: within the first 24hours after injection

    Occurrence of systemic adverse events

  5. Systemic adverse events

    Time frame: 3 days after the infusion

    Occurrence of systemic adverse events

  6. Systemic adverse events

    Time frame: 7 days after the infusion

    Occurrence of systemic adverse events

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: DAPTOSC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 16, 2020
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.