Retrospective Real-word Study of Linezolid for the Treatment of Tuberculous Meningitis

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Tuberculous meningitis
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Brief Title

Retrospective Real-word Study of Linezolid for the Treatment of Tuberculous Meningitis

Official Title

Retrospective Real-word Study of Linezolid for the Treatment of Tuberculous Meningitis

Brief Summary

      Tuberculous meningitis (TBM) is the most serious form of Mycobacterium tuberculosis
      infection, causing mortality and disability in more than half of the patients. Current
      standard treatment for TBM is based on those developed to treat pulmonary tuberculosis, which
      does not take into account the differential ability of anti-tuberculosis drugs to penetrate
      the brain. With both good central nervous system penetrance and anti-tuberculosis efficacy
      that have been demonstrated in drug-resistant tuberculosis, linezolid may be a promising
      antimicrobial in TBM treatment. The purpose of this study is to evaluate the effectiveness of
      linezolid in the treatment of TBM.

Study Type

Observational

Primary Outcome

Survival

Secondary Outcome

 Number of participants with Medical Research Council grade deterioration

Condition

Tuberculous Meningitis

Intervention

Linezolid

Study Arms / Comparison Groups

 Background group
Description:  The treatment regimen does not include linezolid throughout the treatment course.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

150

Start Date

January 1, 2018

Completion Date

June 1, 2019

Primary Completion Date

May 1, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  all patients diagnosed as TBM from the electronic medical record system.

        Exclusion Criteria:

          -  Does not meet the established diagnostic criteria;

          -  Combine other pathogen central infections;

          -  Follow-up confirmed that the final diagnosis considers other diseases (such as tumors,
             autoimmune encephalitis, etc.);

          -  Our hospital has less than one week of anti-tuberculosis treatment;

          -  Lack of information

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, (86)18801734036, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT03898635

Organization ID

2017-44

Responsible Party

Principal Investigator

Study Sponsor

Huashan Hospital

Study Sponsor

, ,

Verification Date

March 2019