AntibioticsPhase 1DAPTOSCNCT04434300
Subcutaneous Daptomycin in Healthy Volunteers (DAPTOSC)
A Phase 1 study testing Daptomycin in people with Antibiotics and Subcutaneous Injection, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibiotics, Subcutaneous Injection, Daptomycin
- What is being tested?
- Daptomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2020to 15 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Pharmacokinetic and the Safety of Daptomycin Administered Subcutaneously Compared to the Intravenous Route : a Cross-over Study
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.
Read more
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
- Being tested
- Daptomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
Compare the pharmacokinetic of subcutaneous (SC) and intravenous (IV) routes in the same patient.
DaptomycinDrug
Compare the pharmacokinetic of subcutaneous (SC) and intravenous (IV) routes in the same patient.
| Study group | Role | What they receive |
|---|---|---|
| Dapto SC-IV | Other | First stage :
* Subcutaneous injection of daptomycin 10mg/kg
* Subcutaneous injection of placebo (physiological serum)
Second stage :
- Intravenous injection of daptomycin 10mg/kg Receives: Drug: Daptomycin |
| Dapto IV-SC | Other | First stage :
- Intravenous injection of daptomycin 10mg/kg
Second stage :
* Subcutaneous injection of daptomycin 10mg/kg
* Subcutaneous injection of placebo (physiological serum) Receives: Drug: Daptomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
daptomycin dosage after intravenous route
measurement of daptomycin blood concentration after intravenous route
Measured: before injection
daptomycin dosage after intravenous route
measurement of daptomycin blood concentration after intravenous route
Measured: 30 minutes after injection
daptomycin dosage after intravenous route
measurement of daptomycin blood concentration after intravenous route
Measured: 1 hours after injection
daptomycin dosage after intravenous route
measurement of daptomycin blood concentration after intravenous route
Measured: 1,50 hours after injection
daptomycin dosage after intravenous route
measurement of daptomycin blood concentration after intravenous route
Measured: 2 hours after injection
daptomycin dosage after intravenous route
measurement of daptomycin blood concentration after intravenous route
Measured: 3 hours after injection
daptomycin dosage after intravenous route
measurement of daptomycin blood concentration after intravenous route
Measured: 4 hours after injection
daptomycin dosage after intravenous route
measurement of daptomycin blood concentration after intravenous route
Measured: 8 hours after injection
daptomycin dosage after intravenous route
measurement of daptomycin blood concentration after intravenous route
Measured: 10 hours after injection
daptomycin dosage after intravenous route
measurement of daptomycin blood concentration after intravenous route
Measured: 24 hours after injection
daptomycin dosage after subcutaneous route
measurement of daptomycin blood concentration after subcutaneous route
Measured: before injection
daptomycin dosage after subcutaneous route
measurement of daptomycin blood concentration after subcutaneous route
Measured: 30 minutes after injection
daptomycin dosage after subcutaneous route
measurement of daptomycin blood concentration after subcutaneous route
Measured: 1 hours after injection
daptomycin dosage after subcutaneous route
measurement of daptomycin blood concentration after subcutaneous route
Measured: 1.50 hours after injection
daptomycin dosage after subcutaneous route
measurement of daptomycin blood concentration after subcutaneous route
Measured: 2 hours after injection
daptomycin dosage after subcutaneous route
measurement of daptomycin blood concentration after subcutaneous route
Measured: 3 hours after injection
daptomycin dosage after subcutaneous route
measurement of daptomycin blood concentration after subcutaneous route
Measured: 4 hours after injection
daptomycin dosage after subcutaneous route
measurement of daptomycin blood concentration after subcutaneous route
Measured: 8 hours after injection
daptomycin dosage after subcutaneous route
measurement of daptomycin blood concentration after subcutaneous route
Measured: 10 hours after injection
daptomycin dosage after subcutaneous route
measurement of daptomycin blood concentration after subcutaneous route
Measured: 24 hours after injection
Secondary outcomes (6)
Local adverse events
Occurrence of local adverse events (pain, erythema, edema, necrosis)
Measured: within the first 24hours after injection
Local adverse events
Occurrence of local adverse events (pain, erythema, edema, necrosis)
Measured: 3 days after the infusion
Local adverse events
Occurrence of local adverse events (pain, erythema, edema, necrosis)
Measured: 7 days after the infusion
Systemic adverse events
Occurrence of systemic adverse events
Measured: within the first 24hours after injection
Systemic adverse events
Occurrence of systemic adverse events
Measured: 3 days after the infusion
Systemic adverse events
Occurrence of systemic adverse events
Measured: 7 days after the infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start15 Oct 2020
- Primary completion15 Jan 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AntibioticsStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434300
- Sponsor's protocol ID
- 2019-004884-32
- Other IDs
- 2019
- Acronym
- DAPTOSC
- Status last verified
- Jul 2021
- First submitted
- 29 Apr 2020
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maurille C, Baldolli A, Creveuil C, Parienti JJ, Michon J, Peyro-Saint-Paul L, Brucato S, Dargere S, Comets E, Verdier MC, Verdon R. Pharmacokinetics and safety of daptomycin administered subcutaneously in healthy volunteers: a single-blinded randomized crossover trial. J Antimicrob Chemother. 2024 Nov 4;79(11):3016-3022. doi: 10.1093/jac/dkae324.
PubMed 39271104
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Pharmacokinetic and the Safety of Daptomycin Administered Subcutaneously Compared to the Intravenous Route : a Cross-over Study
- ClinicalTrials.gov ID
- NCT04434300
- Acronym / sponsor ID
- DAPTOSC / 2019-004884-32
- Conditions
- Antibiotics, Subcutaneous Injection, Daptomycin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapto SC-IV | Other | Drug: DaptomycinFirst stage : * Subcutaneous injection of daptomycin 10mg/kg * Subcutaneous injection of placebo (physiological serum) Second stage : - Intravenous injection of daptomycin 10mg/kg |
| Dapto IV-SC | Other | Drug: DaptomycinFirst stage : - Intravenous injection of daptomycin 10mg/kg Second stage : * Subcutaneous injection of daptomycin 10mg/kg * Subcutaneous injection of placebo (physiological serum) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaptomycinCompare the pharmacokinetic of subcutaneous (SC) and intravenous (IV) routes in the same patient. | Drug | Dapto SC-IV |
| DaptomycinCompare the pharmacokinetic of subcutaneous (SC) and intravenous (IV) routes in the same patient. | Drug | Dapto IV-SC |
Primary outcome
daptomycin dosage after intravenous route
Time frame: before injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route
Time frame: 30 minutes after injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route
Time frame: 1 hours after injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route
Time frame: 1,50 hours after injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route
Time frame: 2 hours after injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route
Time frame: 3 hours after injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route
Time frame: 4 hours after injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route
Time frame: 8 hours after injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route
Time frame: 10 hours after injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route
Time frame: 24 hours after injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after subcutaneous route
Time frame: before injection
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route
Time frame: 30 minutes after injection
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route
Time frame: 1 hours after injection
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route
Time frame: 1.50 hours after injection
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route
Time frame: 2 hours after injection
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route
Time frame: 3 hours after injection
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route
Time frame: 4 hours after injection
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route
Time frame: 8 hours after injection
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route
Time frame: 10 hours after injection
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route
Time frame: 24 hours after injection
measurement of daptomycin blood concentration after subcutaneous route
6 secondary outcomes
Local adverse events
Time frame: within the first 24hours after injection
Local adverse events
Time frame: 3 days after the infusion
Local adverse events
Time frame: 7 days after the infusion
Systemic adverse events
Time frame: within the first 24hours after injection
Systemic adverse events
Time frame: 3 days after the infusion
Systemic adverse events
Time frame: 7 days after the infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Results publication: PubMed 39271104Maurille C, Baldolli A, Creveuil C, Parienti JJ, Michon J, Peyro-Saint-Paul L, Brucato S, Dargere S, Comets E, Verdier MC, Verdon R. Pharmacokinetics and safety of daptomycin administered subcutaneously in healthy volunteers: a single-blinded randomized crossover trial. J Antimicrob Chemother. 2024 Nov 4;79(11):3016-3022. doi: 10.1093/jac/dkae324.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Daptomycin in people with Antibiotics and Subcutaneous Injection, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
daptomycin dosage after intravenous route (time frame: before injection). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04434300, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.