Plasma and Lung Tissue Concentrations of Linezolid in Septic Shock Patients

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.

Study Overview

• Status: Unknown
• Conditions: Septic Shock

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 Type: Observational
• Enrollment (Anticipated): 46

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed as severe pneumonia requiring mechanical ventilatory support.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Experimental Group; septic shock patients;
Conrol Group; non-septic shock patients;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, Day 3, Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial eradication	blood and respiratory secretions culture	Baseline, Day 3, Day 7

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	the outcomes of the patients will be recorded	28-mortality and 60-mortality

Collaborators and Investigators

• Sponsor: Southeast University, China
• Collaborators: Cttq
• Investigators: Principal Investigator: Yingzi Yingzi, PHD, Southeast university

Study record dates

Study Major Dates

• Study Start (Anticipated): October 20, 2017
• Primary Completion (Anticipated): February 28, 2018
• Study Completion (Anticipated): April 30, 2018

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: October 8, 2017
• First Posted (Actual): October 12, 2017

Study Record Updates

• Last Update Posted (Actual): October 12, 2017
• Last Update Submitted That Met QC Criteria: October 8, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Linezolid; PK/PD; Septic shock
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: 2017ZDSYLL051-P01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No