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

March 29, 2019 updated by: Wen-hong Zhang, Huashan Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200040
        • Recruiting
        • Infectious department of Huashan Hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with central nervous system tuberculosis diagnosed and treated at Huashan Hospital.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Background group
The treatment regimen does not include linezolid throughout the treatment course.
Background-linezolid group
Linezolid was added in the middle of the treatment course but not in the initial treatment regimen.
Drug: Linezolid
To add linezolid 600mg or 1200mg daily in the initial or subsequent treatment regimen of TBM.
Linezolid initial group
Linezolid was in initial treatment regimen.
Drug: Linezolid
To add linezolid 600mg or 1200mg daily in the initial or subsequent treatment regimen of TBM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Medical Research Council grade deterioration
Time Frame: From the beginning of anti-tuberculosis treatment to the first documented progression, assessed up to 5 years.
From the beginning of anti-tuberculosis treatment to the first documented progression, assessed up to 5 years.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of Glasgow Coma Scale recovered to 15
Time Frame: From the beginning of anti-tuberculosis treatment to the first documented recovery, assessed up to 5 years.
From the beginning of anti-tuberculosis treatment to the first documented recovery, assessed up to 5 years.
Time of body temperature returns to normal
Time Frame: From the beginning of anti-tuberculosis treatment to the first documented recovery, assessed up to 5 years.
From the beginning of anti-tuberculosis treatment to the first documented recovery, assessed up to 5 years.
Number of participants with new omplications
Time Frame: From the beginning of anti-tuberculosis treatment to the first documented progression, assessed up to 5 years.
Hydrocephalus, cerebral infarction, epilepsy, brain abscess, tuberculoma
From the beginning of anti-tuberculosis treatment to the first documented progression, assessed up to 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ANTICIPATED)

May 1, 2019

Study Completion (ANTICIPATED)

June 1, 2019

Study Registration Dates

First Submitted

March 28, 2019

First Submitted That Met QC Criteria

March 29, 2019

First Posted (ACTUAL)

April 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 2, 2019

Last Update Submitted That Met QC Criteria

March 29, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-44

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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