NCT03308227

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

October 20, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

4 months

First QC Date

September 22, 2017

Last Update Submit

October 8, 2017

Conditions

Septic Shock

Keywords

Linezolid; PK/PD; Septic shock

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Bacterial eradication

    Baseline, Day 3, Day 7

Other Outcomes (1)

  • mortality

    28-mortality and 60-mortality

Study Arms (2)

Experimental Group

septic shock patients;

Conrol Group

non-septic shock patients;

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed as severe pneumonia requiring mechanical ventilatory support.

You may qualify if:

  • 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.

You may not qualify if:

  • Unable to take bronchoalveolar lavage via bronchofiberscopy;
  • Allergy, hypersensitivity or a serious reaction to linezolid;
  • Treatment with linezolid during the previous 72 hours;
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Yingzi Yingzi, PHD

    Southeast University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haibo Qiu, PHD

CONTACT

8602583262550haiboq2000@163.com

Yingzi Huang, PHD

CONTACT

8602583262550Yz_huang@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief doctor

Study Record Dates

First Submitted

September 22, 2017

First Posted

October 12, 2017

Study Start

October 20, 2017

Primary Completion

February 28, 2018

Study Completion

April 30, 2018

Last Updated

October 12, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share