Tuberculous MeningitisNCT03898635
Retrospective Real-word Study of Linezolid for the Treatment of Tuberculous Meningitis
An observational study of Tuberculous Meningitis, run by Huashan Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculous Meningitis
- What is being tested?
- Linezolid
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with central nervous system tuberculosis diagnosed and treated at Huashan Hospital.
Who may be able to join
- all patients diagnosed as TBM from the electronic medical record system.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Feng Sun contact
China1 site, 1 recruiting
- Recruiting
Infectious department of Huashan Hospital, Fudan University
Shanghai, 200040
Wenhong Zhang, (86)52889999, zhangwenhong@fudan.edu.cn
About this study
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
- Being tested
- Linezolid
- Keywords
- linezolid
- Medical subject headings
- Tuberculosis, Meningeal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinezolidDrug
To add linezolid 600mg or 1200mg daily in the initial or subsequent treatment regimen of TBM.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Linezolid | |
| Linezolid initial group | Linezolid was in initial treatment regimen. Receives: Drug: Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 5 years
Secondary outcomes (1)
Number of participants with Medical Research Council grade deterioration
Measured: From the beginning of anti-tuberculosis treatment to the first documented progression, assessed up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Jan 2018
- Primary completion1 May 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculous MeningitisStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898635
- Sponsor's protocol ID
- 2017-44
- Status last verified
- Mar 2019
- First submitted
- 28 Mar 2019
- Last updated
- 2 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Real-word Study of Linezolid for the Treatment of Tuberculous Meningitis
- ClinicalTrials.gov ID
- NCT03898635
- Acronym / sponsor ID
- 2017-44
- Conditions
- Tuberculous Meningitis
- Keywords
- linezolid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Background group | – | –The treatment regimen does not include linezolid throughout the treatment course. |
| Background-linezolid group | – | Drug: LinezolidLinezolid was added in the middle of the treatment course but not in the initial treatment regimen. |
| Linezolid initial group | – | Drug: LinezolidLinezolid was in initial treatment regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with central nervous system tuberculosis diagnosed and treated at Huashan Hospital.
Key inclusion criteria (1 listed)
- all patients diagnosed as TBM from the electronic medical record system.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LinezolidTo add linezolid 600mg or 1200mg daily in the initial or subsequent treatment regimen of TBM. | Drug | Background-linezolid group, Linezolid initial group |
Primary outcome
Survival
Time frame: 5 years
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng Sun contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculous Meningitis, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xian Zhou ((86)18801734036, zhouxian-13@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.