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

NCT ID: NCT03898635

Last Updated: 2019-04-02

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

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Tuberculous Meningitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Background group

The treatment regimen does not include linezolid throughout the treatment course.

No interventions assigned to this group

Background-linezolid group

Linezolid was added in the middle of the treatment course but not in the initial treatment regimen.

Linezolid

Intervention Type DRUG

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.

Linezolid

Intervention Type DRUG

To add linezolid 600mg or 1200mg daily in the initial or subsequent treatment regimen of TBM.

Interventions

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Linezolid

To add linezolid 600mg or 1200mg daily in the initial or subsequent treatment regimen of TBM.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wen-hong Zhang

Director of Division of Infectious Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Infectious department of Huashan Hospital, Fudan University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xian Zhou

Role: CONTACT

(86)18801734036

Feng Sun

Role: CONTACT

Facility Contacts

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Wenhong Zhang

Role: primary

(86)52889999

Other Identifiers

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2017-44

Identifier Type: -

Identifier Source: org_study_id

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