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

Tuberculous Meningitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03898635
• Other study ID #: 2017-44
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: March 2019
• Source: Huashan Hospital
• Contact: Xian Zhou
• Phone: (86)18801734036
• Email: zhouxian-13[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Meningitis
• Tuberculosis
• Tuberculosis, Meningeal
• Tuberculous Meningitis

Intervention

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

Locations

Country	Name	City	State
China	Infectious department of Huashan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	Time of body temperature returns to normal		From the beginning of anti-tuberculosis treatment to the first documented recovery, assessed up to 5 years.
Other	Number of participants with new omplications	Hydrocephalus, cerebral infarction, epilepsy, brain abscess, tuberculoma	From the beginning of anti-tuberculosis treatment to the first documented progression, assessed up to 5 years.
Primary	Survival		5 years
Secondary	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.