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

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Fudan University

Status

Unknown

Conditions

Tuberculous Meningitis

Treatments

Drug: Linezolid

Study type

Observational

Funder types

Other

Identifiers

NCT03898635
2017-44

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

150 participants in 3 patient groups

Background group
Description:
The treatment regimen does not include linezolid throughout the treatment course.
Background-linezolid group
Description:
Linezolid was added in the middle of the treatment course but not in the initial treatment regimen.
Treatment:
Drug: Linezolid
Linezolid initial group
Description:
Linezolid was in initial treatment regimen.
Treatment:
Drug: Linezolid

Trial contacts and locations

1

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Central trial contact

Xian Zhou; Feng Sun

Data sourced from clinicaltrials.gov

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