Septic ShockNCT02508350
The Pharmacokinetics/Pharmacodynamics of High-dose Daptomycin in Patients With Septic Shock
A study testing Daptomycin and determination of plasma concentration in people with Septic Shock, run by Zhongda Hospital at 1 site in China.
Trial summary
The first objective of this study was to characterize the pharmacokinetics and pharmacodynamics of daptomycin with a daily dose of 12mg/kg in septic shock patient; the second objective is to identify the optimal dosing scheme for daptomycin among patients with septic shock and to enhance therapeutic outcomes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Daptomycin and determination of plasma concentration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Jun 2016
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years and ≤75 years
- confirmed or suspected bloodstream and soft tissue infections caused by a grampositive organism
Who cannot join
- known hypersensitivity to daptomycin or product excipients
- documented or suspected pneumonia caused by a grampositive organism
- infection with a daptomycin-resistant organism
- presence or history of rhabdomyolysis
- signs or symptoms of myopathy with an elevation of creatine phosphokinase concentrations 6.pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda hospital, Southeast University
Nanjing, Jiangsu, 210009
Nan Guo, 15850681416, guonan8910@163.com
About this study
Official title: The Pharmacokinetics and Pharmacodynamics of High-dose Daptomycin in Patients With Septic Shock
The first objective of this study was to characterize the pharmacokinetics and pharmacodynamics of daptomycin with a daily dose of 12mg/kg in septic shock patient; the second objective is to identify the optimal dosing scheme for daptomycin among patients with septic shock and to enhance therapeutic outcomes.
Read the detailed description
Daptomycin is a novel lipopeptide exhibiting concentration-dependent bactericidal activity against multidrug-resistant Gram-positive pathogens, including Methicillin-resistant Staphylococcus aureus (MRSA). In recent years, daptomycin plays an important role in the treatment of septic shock. The pharmacokinetics of daptomycin is significant changed in patients with septic shock, it is proved that the recent dosage regiment comes with a low blood drug concentration and unsatisfactory outcome. Although the high-dose daptomycin shows safety and effectiveness in the treatment of critically ill patient, but still the pharmacokinetics and pharmacodynamics data is scant. So the purposes of this study is to characterize the pharmacokinetics and pharmacodynamics of daptomycin with a daily dose of 12mg/kg in septic shock patient; the second objective is to identify the optimal dosing scheme for daptomycin among patients with septic shock and to enhance therapeutic outcomes.
- Conditions
- Septic Shock
- Being tested
- Daptomycin, determination of plasma concentration
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
Also called Cubicin
Drug: Daptomycin for Injection（Cubicin,AstraZeneca） dosage: 10-12mg/kg/day frequency: once a day duration: 14 days
determination of plasma concentrationOther
A maximum of 12 blood samples (1.5mL) were collected in Ethylenediaminetetraacetic acid disodium salt (EDTA-Na2) tubes over a 6-dose administration sequence.Sampling was done prior to the administration of the first dose, at 30 minutes (end of infusion),and at 4,12,and 24 hours after the initial dose.Additional blood samples were collected at the end of infusion (peak) and prior to the subsequent dose (trough) for doses 2-5.After the sixth dose the blood samples were collected prior to the administration and at 4,and 24 hours after the end of infusion.
| Study group | Role | What they receive |
|---|---|---|
| daptomycin | Experimental | Daptomycin for injection 10-12mg/kg/day,determination of plasma concentration Receives: Drug: Daptomycin; Other: determination of plasma concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve(AUC)/Minimum inhibitory concentration(MIC)
Measured: 6 days
Peak concentration (Cmax)/Minimum inhibitory concentration(MIC)
Measured: 6 days
Secondary outcomes (1)
mortality rate
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingzi Huang, Zhongda Hospital
- Investigators
- Yingzi - Huang, Study director, southeast univerity, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508350
- Sponsor's protocol ID
- 2015Dapto
- Status last verified
- Jul 2015
- First submitted
- 18 Jul 2015
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics and Pharmacodynamics of High-dose Daptomycin in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT02508350
- Acronym / sponsor ID
- 2015Dapto
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 24 Jul 2015 (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 first objective of this study was to characterize the pharmacokinetics and pharmacodynamics of daptomycin with a daily dose of 12mg/kg in septic shock patient; the second objective is to identify the optimal dosing scheme for daptomycin among patients with septic shock and to enhance therapeutic outcomes.
Detailed description
Daptomycin is a novel lipopeptide exhibiting concentration-dependent bactericidal activity against multidrug-resistant Gram-positive pathogens, including Methicillin-resistant Staphylococcus aureus (MRSA). In recent years, daptomycin plays an important role in the treatment of septic shock. The pharmacokinetics of daptomycin is significant changed in patients with septic shock, it is proved that the recent dosage regiment comes with a low blood drug concentration and unsatisfactory outcome. Although the high-dose daptomycin shows safety and effectiveness in the treatment of critically ill patient, but still the pharmacokinetics and pharmacodynamics data is scant. So the purposes of this study is to characterize the pharmacokinetics and pharmacodynamics of daptomycin with a daily dose of 12mg/kg in septic shock patient; the second objective is to identify the optimal dosing scheme for daptomycin among patients with septic shock and to enhance therapeutic outcomes.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| daptomycin | Experimental | Drug: Daptomycin, Other: determination of plasma concentrationDaptomycin for injection 10-12mg/kg/day,determination of plasma concentration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥18 years and ≤75 years
- confirmed or suspected bloodstream and soft tissue infections caused by a grampositive organism
Key exclusion criteria (5 listed)
- known hypersensitivity to daptomycin or product excipients
- documented or suspected pneumonia caused by a grampositive organism
- infection with a daptomycin-resistant organism
- presence or history of rhabdomyolysis
- signs or symptoms of myopathy with an elevation of creatine phosphokinase concentrations 6.pregnancy or breast-feeding
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 |
|---|---|---|
| DaptomycinAlso: CubicinDrug: Daptomycin for Injection（Cubicin,AstraZeneca） dosage: 10-12mg/kg/day frequency: once a day duration: 14 days | Drug | daptomycin |
| determination of plasma concentrationA maximum of 12 blood samples (1.5mL) were collected in Ethylenediaminetetraacetic acid disodium salt (EDTA-Na2) tubes over a 6-dose administration sequence.Sampling was done prior to the administration of the first dose, at 30 minutes (end of infusion),and at 4,12,and 24 hours after the initial dose.Additional blood samples were collected at the end of infusion (peak) and prior to the subsequent dose (trough) for doses 2-5.After the sixth dose the blood samples were collected prior to the administration and at 4,and 24 hours after the end of infusion. | Other | daptomycin |
Primary outcome
Area under the curve(AUC)/Minimum inhibitory concentration(MIC)
Time frame: 6 days
Peak concentration (Cmax)/Minimum inhibitory concentration(MIC)
Time frame: 6 days
1 secondary outcome
mortality rate
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
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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.
Yingzi - Huang study director
southeast univerity, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daptomycin and determination of plasma concentration in people with Septic Shock, run by Zhongda Hospital at 1 site in China.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Jul 2015. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingzi - Huang, doctor (13951693278, yz_huang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve(AUC)/Minimum inhibitory concentration(MIC) (time frame: 6 days). The study lists 2 primary outcomes in all. 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 24 Jul 2015.