Burn InjuryPhase 4NCT02241941
Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury
A Phase 4 study testing Daptomycin in people with Burn Injury, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine single dose pharmacokinetics of daptomycin consecutively in 10 patients on three different time points after severe burn injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Injury
- What is being tested?
- Daptomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2014to Oct 2016
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female of 18 years or older
- Second and/or third degree thermal injury
- Total body surface area burned ≥ 15%
- Hospitalisation in the ICU for burn injured patients of the University Hospital Zürich
- Probability of ICU stay of >14 days
- Written informed consent by the patient or in patients unable to be informed or to sign according to section 4.4 of the study protocol
Who cannot join
- Evidence of renal failure (Creatinine clearance <30ml/min) or continuous renal replacement therapy such as continuous hemofiltration
- History of muscle disease or skeletal muscle disorder
- Creatine-phosphokinase (CPK) ≥ 5 times the upper limit of normal (ULN)
- History of hypersensitivity to the drug
- Pregnancy
- Severe coagulation disorder
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine single dose pharmacokinetics of daptomycin consecutively in 10 patients on three different time points after severe burn injury.
- Conditions
- Burn Injury
- Being tested
- Daptomycin
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
| Study group | Role | What they receive |
|---|---|---|
| Daptomycin | Experimental | Not described Receives: Drug: Daptomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters of daptomycin
Measured: up to 30 days
Secondary outcomes (2)
Correlation of daptomycin plasma concentrations with tissue concentration
Measured: up to 30 days
degree of variability of daptomycin pk parameters in dependency of body surface area burned
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Assessment of daptomycin concentrations with microdialysis technically not feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainer Weber, MD Professor, Principal investigator, Division of Infectious Diseases and Hospital Epidemiology, Universitit Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241941
- Sponsor's protocol ID
- Dapto-ICU-09
- Other IDs
- EK-1748
- Status last verified
- Oct 2016
- First submitted
- 13 Sep 2014
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury
- ClinicalTrials.gov ID
- NCT02241941
- Acronym / sponsor ID
- Dapto-ICU-09
- Conditions
- Burn Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Assessment of daptomycin concentrations with microdialysis technically not feasible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 16 Sep 2014 (estimated)
- 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.
The purpose of this study is to determine single dose pharmacokinetics of daptomycin consecutively in 10 patients on three different time points after severe burn injury.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daptomycin | Experimental | Drug: Daptomycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female of 18 years or older
- Second and/or third degree thermal injury
- Total body surface area burned ≥ 15%
- Hospitalisation in the ICU for burn injured patients of the University Hospital Zürich
- Probability of ICU stay of >14 days
Key exclusion criteria (6 listed)
- Evidence of renal failure (Creatinine clearance <30ml/min) or continuous renal replacement therapy such as continuous hemofiltration
- History of muscle disease or skeletal muscle disorder
- Creatine-phosphokinase (CPK) ≥ 5 times the upper limit of normal (ULN)
- History of hypersensitivity to the drug
- Pregnancy
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 |
|---|---|---|
| Daptomycin | Drug | Daptomycin |
Primary outcome
Pharmacokinetic parameters of daptomycin
Time frame: up to 30 days
2 secondary outcomes
Correlation of daptomycin plasma concentrations with tissue concentration
Time frame: up to 30 days
degree of variability of daptomycin pk parameters in dependency of body surface area burned
Time frame: up to 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
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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.
Rainer Weber, MD Professor principal investigator
Division of Infectious Diseases and Hospital Epidemiology, Universitit Hospital Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Daptomycin in people with Burn Injury, run by University of Zurich at 1 site in Switzerland.
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 6 inclusion and 6 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: withdrawn, as of the sponsor's last update on 28 Oct 2016. 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 Switzerland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Pharmacokinetic parameters of daptomycin (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2016.