Plasma and Lung Tissue Concentrations of Linezolid in Septic Shock Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-20

Study Completion Date

2018-04-30

Brief Summary

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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

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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

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Septic Shock

Keywords

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Linezolid; PK/PD; Septic shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental Group

septic shock patients;

No interventions assigned to this group

Conrol Group

non-septic shock patients;

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jingyuan,Xu

chief doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yingzi Yingzi, PHD

Role: PRINCIPAL_INVESTIGATOR

Southeast University

Central Contacts

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Haibo Qiu, PHD

Role: CONTACT

Phone: 8602583262550

Email: [email protected]

Yingzi Huang, PHD