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Plasma and Lung Tissue Concentrations of Linezolid in Septic Shock Patients

This study is not yet open for participant recruitment.
Verified October 2017 by Jingyuan,Xu, Southeast University, China
Sponsor:
ClinicalTrials.gov Identifier:
NCT03308227
First Posted: October 12, 2017
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Cttq
Information provided by (Responsible Party):
Jingyuan,Xu, Southeast University, China
  Purpose
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.

Condition
Septic Shock

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Plasma and Lung Tissue Concentrations of Linezolid in Septic Shock Patients

Resource links provided by NLM:


Further study details as provided by Jingyuan,Xu, Southeast University, China:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Bacterial eradication [ Time Frame: Baseline, Day 3, Day 7 ]
    blood and respiratory secretions culture


Other Outcome Measures:
  • mortality [ Time Frame: 28-mortality and 60-mortality ]
    the outcomes of the patients will be recorded


Estimated Enrollment: 46
Anticipated Study Start Date: October 20, 2017
Estimated Study Completion Date: April 30, 2018
Estimated Primary Completion Date: February 28, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Experimental Group
septic shock patients;
Conrol Group
non-septic shock patients;

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed as severe pneumonia requiring mechanical ventilatory support.
Criteria

Inclusion Criteria:

  1. between 18 years old and 75 years old;
  2. Admitted to the ICU;
  3. Expectation, in the opinion of the investigator, that the patients' infection will require ICU stay more than 3 days;
  4. Patients diagnosed as severe pneumonia requiring mechanical ventilatory support;
  5. Severe pneumonia known or suspected to be caused by Gram-positive pathogens;
  6. Expected to treat with linezolid.

Exclusion Criteria:

  1. Unable to take bronchoalveolar lavage via bronchofiberscopy;
  2. Allergy, hypersensitivity or a serious reaction to linezolid;
  3. Treatment with linezolid during the previous 72 hours;
  4. Pregnancy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308227


Contacts
Contact: Haibo Qiu, PHD 8602583262550 haiboq2000@163.com
Contact: Yingzi Huang, PHD 8602583262550 Yz_huang@126.com

Sponsors and Collaborators
Southeast University, China
Cttq
Investigators
Principal Investigator: Yingzi Yingzi, PHD Southeast University
  More Information

Responsible Party: Jingyuan,Xu, chief doctor, Southeast University, China
ClinicalTrials.gov Identifier: NCT03308227     History of Changes
Other Study ID Numbers: 2017ZDSYLL051-P01
First Submitted: September 22, 2017
First Posted: October 12, 2017
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jingyuan,Xu, Southeast University, China:
Linezolid; PK/PD; Septic shock

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action