Septic ShockNCT03308227
Plasma and Lung Tissue Concentrations of Linezolid in Septic Shock Patients
An observational study of Septic Shock, run by Southeast University, China.
Trial summary
The study measures the plasma and bronchoalveolar lavage fluid concentrations of linezolid in septic shock patients comparing with non-septic shock patients to confirm the impact of septic shock on PK/PD of linezolid. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Septic Shock
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2017to 30 Apr 2018
- Phase
- Observational
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed as severe pneumonia requiring mechanical ventilatory support.
Who may be able to join
- between 18 years old and 75 years old;
- Admitted to the ICU;
- Expectation, in the opinion of the investigator, that the patients' infection will require ICU stay more than 3 days;
- Patients diagnosed as severe pneumonia requiring mechanical ventilatory support;
- Severe pneumonia known or suspected to be caused by Gram-positive pathogens;
- Expected to treat with linezolid.
Who cannot join
- Unable to take bronchoalveolar lavage via bronchofiberscopy;
- Allergy, hypersensitivity or a serious reaction to linezolid;
- Treatment with linezolid during the previous 72 hours;
- Pregnancy.
Trial locations and contacts
No sites are listed yet.
About this study
The study measures the plasma and bronchoalveolar lavage fluid concentrations of linezolid in septic shock patients comparing with non-septic shock patients to confirm the impact of septic shock on PK/PD of linezolid.
Read the detailed description
A wide array of pathophysiological changes occurring in severe sepsis and septic shock patients may influence antibiotics' pharmacokinetic (PK) properties. The pharmacokinetics and tissue distributions of linezolid achieving effective concentrations are key factors of successful clinical outcomes. To the best of our knowledge, no observational clinical studies are available on the plasma and bronchoalveolar lavage fluid concentrations of linezolid in septic shock patients. Severe pneumonia patients known or suspected to be caused by Gram-positive pathogens will be considered eligible for the study when the attending physician prescribed linezolid as treatment. The plasma and bronchoalveolar lavage fluid concentrations of linezolid are measured in each group at steady state. In an in vitro PK Model, concentration-time curve is drawn to calculate %T>MIC or AUC0-24h/MIC. Linezolid pharmacodynamics evaluation should be based on bacterial eradication and clinical outcomes.
- Conditions
- Septic Shock
- Keywords
- Linezolid; PK/PD; Septic shock
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | septic shock patients; | |
| Conrol Group | non-septic shock patients; |
What is being measured
The primary outcome is the main question the study is designed to answer.
The plasma and bronchoalveolar lavage fluid concentrations of linezolid
The plasma and bronchoalveolar lavage fluid concentrations of linezolid are measured in each group at steady state
Measured: Baseline, Day 3, Day 7
Secondary outcomes (1)
Bacterial eradication
blood and respiratory secretions culture
Measured: Baseline, Day 3, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start20 Oct 2017 (estimated)
- Primary completion28 Feb 2018 (estimated)
- Study completion30 Apr 2018 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Cttq
- Responsible party
- Principal investigator, Jingyuan,Xu, Southeast University, China
- Investigators
- Yingzi Yingzi, PHD, Principal investigator, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308227
- Sponsor's protocol ID
- 2017ZDSYLL051-P01
- Status last verified
- Oct 2017
- First submitted
- 22 Sep 2017
- Last updated
- 12 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma and Lung Tissue Concentrations of Linezolid in Septic Shock Patients
- ClinicalTrials.gov ID
- NCT03308227
- Acronym / sponsor ID
- 2017ZDSYLL051-P01
- Conditions
- Septic Shock
- Keywords
- Linezolid; PK/PD; Septic shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- Cttq
- Study start
- 20 Oct 2017 (estimated)
- Primary completion
- 28 Feb 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 12 Oct 2017 (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.
The study measures the plasma and bronchoalveolar lavage fluid concentrations of linezolid in septic shock patients comparing with non-septic shock patients to confirm the impact of septic shock on PK/PD of linezolid.
Detailed description
A wide array of pathophysiological changes occurring in severe sepsis and septic shock patients may influence antibiotics' pharmacokinetic (PK) properties. The pharmacokinetics and tissue distributions of linezolid achieving effective concentrations are key factors of successful clinical outcomes. To the best of our knowledge, no observational clinical studies are available on the plasma and bronchoalveolar lavage fluid concentrations of linezolid in septic shock patients. Severe pneumonia patients known or suspected to be caused by Gram-positive pathogens will be considered eligible for the study when the attending physician prescribed linezolid as treatment. The plasma and bronchoalveolar lavage fluid concentrations of linezolid are measured in each group at steady state. In an in vitro PK Model, concentration-time curve is drawn to calculate %T>MIC or AUC0-24h/MIC. Linezolid pharmacodynamics evaluation should be based on bacterial eradication and clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | –septic shock patients; |
| Conrol Group | – | –non-septic shock patients; |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed as severe pneumonia requiring mechanical ventilatory support.
Key inclusion criteria (6 listed)
- between 18 years old and 75 years old;
- Admitted to the ICU;
- Expectation, in the opinion of the investigator, that the patients' infection will require ICU stay more than 3 days;
- Patients diagnosed as severe pneumonia requiring mechanical ventilatory support;
- Severe pneumonia known or suspected to be caused by Gram-positive pathogens;
Key exclusion criteria (4 listed)
- Unable to take bronchoalveolar lavage via bronchofiberscopy;
- Allergy, hypersensitivity or a serious reaction to linezolid;
- Treatment with linezolid during the previous 72 hours;
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The plasma and bronchoalveolar lavage fluid concentrations of linezolid
Time frame: Baseline, Day 3, Day 7
The plasma and bronchoalveolar lavage fluid concentrations of linezolid are measured in each group at steady state
1 secondary outcome
Bacterial eradication
Time frame: Baseline, Day 3, Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Individual participant dataSharing planned: No
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Septic Shock
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 Yingzi, PHD principal investigator
Southeast University
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Southeast University, 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 6 inclusion and 4 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 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Haibo Qiu, PHD (8602583262550, haiboq2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The plasma and bronchoalveolar lavage fluid concentrations of linezolid (time frame: Baseline, Day 3, Day 7). 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 12 Oct 2017; AzTrials last refreshed its copy on 7 Nov 2026.