Plasma and Lung Tissue Concentrations of Linezolid in Septic Shock Patients

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03308227

Enrollment

Registered

2017-10-12

Start date

2017-10-20

Completion date

2018-04-30

Last updated

2017-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

Linezolid; PK/PD; Septic shock

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The plasma and bronchoalveolar lavage fluid concentrations of linezolid	Baseline, Day 3, Day 7	The plasma and bronchoalveolar lavage fluid concentrations of linezolid are measured in each group at steady state

Secondary

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

Other

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

Contacts

Primary ContactHaibo Qiu, PHD

haiboq2000@163.com8602583262550

Backup ContactYingzi Huang, PHD

Yz_huang@126.com8602583262550

Outcome results