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Trial record 12 of 23 for:    "Bacterial Meningitis" | "Anti-Bacterial Agents"

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

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ClinicalTrials.gov Identifier: NCT03898635
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Wen-hong Zhang, Huashan Hospital

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.

Condition or disease Intervention/treatment
Tuberculous Meningitis Drug: Linezolid

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Real-word Study of Linezolid for the Treatment of Tuberculous Meningitis
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Linezolid

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.




Primary Outcome Measures :
  1. Survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. 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. ]

Other Outcome Measures:
  1. 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. ]
  2. 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. ]
  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with central nervous system tuberculosis diagnosed and treated at Huashan Hospital.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898635


Contacts
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Contact: Xian Zhou (86)18801734036 zhouxian-13@163.com
Contact: Feng Sun aaronsf1125@126.com

Locations
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China
Infectious department of Huashan Hospital, Fudan University Recruiting
Shanghai, China, 200040
Contact: Wenhong Zhang    (86)52889999    zhangwenhong@fudan.edu.cn   
Sponsors and Collaborators
Huashan Hospital

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Responsible Party: Wen-hong Zhang, Director of Division of Infectious Diseases, Huashan Hospital
ClinicalTrials.gov Identifier: NCT03898635     History of Changes
Other Study ID Numbers: 2017-44
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wen-hong Zhang, Huashan Hospital:
linezolid
Additional relevant MeSH terms:
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Meningitis, Bacterial
Anti-Bacterial Agents
Tuberculosis
Tuberculosis, Meningeal
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Central Nervous System Bacterial Infections
Tuberculosis, Central Nervous System
Central Nervous System Infections
Linezolid
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action