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

NCT03898635 | Unknown

• 1 other identifier: 2017-44
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculous Meningitis

Keywords

linezolid

Outcome Measures

Primary Outcomes (1)

• Survival

  5 years

Secondary Outcomes (1)

• Number of participants with Medical Research Council grade deterioration

  From the beginning of anti-tuberculosis treatment to the first documented progression, assessed up to 5 years.

Other Outcomes (3)

• Time of Glasgow Coma Scale recovered to 15

  From the beginning of anti-tuberculosis treatment to the first documented recovery, assessed up to 5 years.

• Time of body temperature returns to normal

  From the beginning of anti-tuberculosis treatment to the first documented recovery, assessed up to 5 years.

• Number of participants with new omplications

  From the beginning of anti-tuberculosis treatment to the first documented progression, assessed up to 5 years.

Study Arms (3)

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

Linezolid initial group

Linezolid was in initial treatment regimen.

Drug: Linezolid

Interventions

Linezolid DRUG

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

Background-linezolid group; Linezolid initial group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Infectious department of Huashan Hospital, Fudan University

Shanghai, 200040, China

RECRUITING

MeSH Terms

Conditions

Tuberculosis, Meningeal

Interventions

Linezolid

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Tuberculosis, Central Nervous System; Tuberculosis, Extrapulmonary; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Xian Zhou

CONTACT

(86)18801734036; zhouxian-13@163.com

Feng Sun

CONTACT

aaronsf1125@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Division of Infectious Diseases

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 2, 2019
• Study Start: January 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 2, 2019

Record last verified: 2019-03

Locations

CN (1)