<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03787940</url>
  </required_header>
  <id_info>
    <org_study_id>2018ZX10302302-004</org_study_id>
    <nct_id>NCT03787940</nct_id>
  </id_info>
  <brief_title>Optimizing Antituberculosis Therapy in Adults With Tuberculous Meningitis</brief_title>
  <official_title>Optimizing Antituberculosis Therapy in Adults With Tuberculous Meningitis Based on N-Acetyltransferase Type 2 Genotyping</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Chest Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Chest Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The genetically polymorphic N-acetyltransferase type 2 (NAT2) is responsible for isoniazid&#xD;
      metabolism, and rapid acetylators were associated with low concentrations of isoniazid based&#xD;
      on previous studies. The investigators hypothesize that among rapid acetylators high dose&#xD;
      isoniazid would result in lower rates of death and disability in patients with tuberculous&#xD;
      meningitis than the rates with the standard regimen. The investigators recruited patients&#xD;
      between the ages of 18 and 65 years with newly diagnosed TBM, then NAT2 genotype will be&#xD;
      characterized by using High-Resolution Melting Kit (Zeesan Company, Xiamen). Participants&#xD;
      with slow or intermediate acetylators will be administered with standard chemotherapy. For&#xD;
      participants with rapid acetylators, patients were stratified at study entry according to the&#xD;
      modified British Medical Research Council criteria (MRC grade), then randomly assigned in a&#xD;
      1:1 ratio to receive either standard or with high dose isoniazid treatment. All patients&#xD;
      received antituberculosis treatment, which consisted of isoniazid (standard dose or high&#xD;
      dose), rifampin, pyrazinamide, ethambutol for 3 months, followed by isoniazid, rifampin and&#xD;
      ethambutol at the same doses for an additional 9 months. All patients received adjunctive&#xD;
      treatment with dexamethasone for the first 6 to 8 weeks of treatment. 338 participants with&#xD;
      rapid acetylators were randomly assigned to group B (standard treatment) and group C (high&#xD;
      dose isoniazid), respectively. At the same time, 338 participants with slow or intermediate&#xD;
      acetylators were recruited to group A (standard treatment). The primary outcome was death or&#xD;
      severe disability 12 months after enrollment. Secondary outcome measures were coma-clearance&#xD;
      time, fever-clearance time, and difference of laboratory examination (protein concentration,&#xD;
      chloride, glucose and white cell counts) of cerebrospinal fluid.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tuberculous meningitis (TBM) is the most lethal form of tuberculosis, causing death or severe&#xD;
      neurologic deficits in more than half of those affected in spite of antituberculosis&#xD;
      chemotherapy. Among the first line drugs, isoniazid is the only bactericidal agent that&#xD;
      easily crossed blood-brain barrier, achieving concentrations in cerebrospinal fluid (CSF)&#xD;
      similar to those in serum. The genetically polymorphic N-acetyltransferase type 2 (NAT2) is&#xD;
      responsible for isoniazid metabolism, and individuals can be classified as &quot;rapid&#xD;
      acetylators&quot;, &quot;intermediate acetylators&quot; or &quot;slow acetylators&quot; based on NAT2 genotyping.&#xD;
      Rapid acetylators were associated with low concentrations of isoniazid based on previous&#xD;
      studies. The investigators hypothesize that among rapid acetylators high dose isoniazid would&#xD;
      result in lower rates of death and disability in patients with tuberculous meningitis than&#xD;
      the rates with the standard regimen.&#xD;
&#xD;
      The investigators recruited patients between the ages of 18 and 65 years with newly diagnosed&#xD;
      TBM. Patients could not enter the trial if they have been using any other second line&#xD;
      antituberculosis drug; if they had received anti-tuberculosis therapy in the past 3 years；if&#xD;
      they have positive CSF Gram or India ink stain; if they have received more than 14 days of&#xD;
      anti-tuberculosis drugs for the current infection; if they were known or suspected&#xD;
      hypersensitivity to or unacceptable side effects from any oral first line antituberculosis&#xD;
      drug; if the plasma creatinine concentration was more than the upper limit of the normal&#xD;
      range, if the plasma bilirubin concentration was more than 2 times the upper limit of the&#xD;
      normal range, or if the plasma alanine aminotransferase level was more than three times the&#xD;
      upper limit of the normal range; if they were known or suspected pregnancy; if they were&#xD;
      known or suspected isoniazid and/or rifampin resistant; if they were lack of consent； if they&#xD;
      were any participant for whom investigators judge this study is not appropriated.&#xD;
&#xD;
      Participants will be recruited from four sites in China, including Beijing Chest Hospital&#xD;
      affiliated to Capital Medical University, Zunyi Medical College affiliated Hospital, Jiangxi&#xD;
      Provincial Chest Hospital and Jiamusi Infectious Disease Hospital. All hospitals serve the&#xD;
      local community and act as tertiary referral centers for patients with severe tuberculosis or&#xD;
      infectious diseases in China.&#xD;
&#xD;
      Written informed consent to participate in the study was obtained from all patients. Then&#xD;
      NAT2 genotype will be characterized by using High-Resolution Melting Kit (Zeesan Company,&#xD;
      Xiamen). Participants with slow or intermediate acetylators will be administered with&#xD;
      standard chemotherapy (3 months HRZE followed by 9 months HRE). For participants with rapid&#xD;
      acetylators, patients were stratified at study entry according to the modified British&#xD;
      Medical Research Council criteria (MRC grade), then randomly assigned in a 1:1 ratio to&#xD;
      receive either standard or high dose isoniazid treatment.&#xD;
&#xD;
      All patients received antituberculosis treatment, which consisted of isoniazid (300 mg for&#xD;
      standard treatment and 900 mg for high dose treatment), rifampin (450 mg for weight no more&#xD;
      than 50 kg, 600 mg for weight more than 50 kg), pyrazinamide (1500 mg for weight no more than&#xD;
      50 kg, 1750 mg for weight more than 50 kg), ethambutol (750 mg for weight no more than 50 kg,&#xD;
      1000 mg for weight more than 50 kg) for 3 months, followed by isoniazid, rifampin and&#xD;
      ethambutol at the same doses for an additional 9 months. All patients received adjunctive&#xD;
      treatment with dexamethasone for the first 6 to 8 weeks of treatment, as recommend by British&#xD;
      Infection Society.&#xD;
&#xD;
      338 participants with rapid acetylators will be randomly assigned to group B (standard&#xD;
      treatment) and group C (high dose isoniazid), respectively. The calculation assumes an&#xD;
      overall mortality and severe disability of 50% vs. 70 % in the two arms, a power of 80% and a&#xD;
      two-sided significance level of 5%. Randomization ration is 1:1. At the same time, 338&#xD;
      participants with slow or intermediate acetylators were recruited to group A (standard&#xD;
      treatment).&#xD;
&#xD;
      The primary outcome was death or severe disability 12 months after enrollment. Secondary&#xD;
      outcome measures were coma-clearance time, fever-clearance time, and difference of CSF&#xD;
      laboratory examination (protein concentration, chloride, glucose and white cell counts) of&#xD;
      cerebrospinal fluid after 3 months treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 4, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with death or severe disability</measure>
    <time_frame>up to 12 months after enrollment</time_frame>
    <description>Number of Participants with death or severe disability 12 months after enrollment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>days for coma-clearance time</measure>
    <time_frame>through study completion,up to 1 year</time_frame>
    <description>days for coma-clearance time through study completion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>days for fever-clearance time</measure>
    <time_frame>through study completion,up to 1 year</time_frame>
    <description>days for fever-clearance time through study completion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>difference of CSF protein concentration</measure>
    <time_frame>3 months after enrollment</time_frame>
    <description>difference of CSF protein concentration (g/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>difference of CSF glucose concentration</measure>
    <time_frame>3 months after enrollment</time_frame>
    <description>difference of CSF glucose concentration (mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>difference of CSF white cell counts</measure>
    <time_frame>3 months after enrollment</time_frame>
    <description>difference of CSF white cell counts (per milliliter)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>difference of CSF chloride concentration</measure>
    <time_frame>3 months after enrollment</time_frame>
    <description>difference of CSF chloride concentration (mmol/L)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">676</enrollment>
  <condition>Tuberculous Meningitis</condition>
  <arm_group>
    <arm_group_label>Standard INH for Non-rapid acetylators</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participant with slow or intermediate acetylators(one of N-Acetyltransferase Type 2 Genotype) administered with standard chemotherapy (3 months HRZE followed by 9 months HRE with standard dose isoniazid)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard INH for rapid acetylators</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participant with rapid acetylators(one of N-Acetyltransferase Type 2 Genotype) administered with standard chemotherapy (3 months HRZE followed by 9 months HRE with standard dose isoniazid )</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose INH for rapid acetylators</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant with rapid acetylators(one of N-Acetyltransferase Type 2 Genotype) administered with high dose isonized treatment (3 months HRZE followed by 9 months HRE with high dose isoniazid)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isoniazid</intervention_name>
    <description>standard dose isoniazid or high dose isoniazid for participants with rapid acetylators</description>
    <arm_group_label>High dose INH for rapid acetylators</arm_group_label>
    <arm_group_label>Standard INH for Non-rapid acetylators</arm_group_label>
    <arm_group_label>Standard INH for rapid acetylators</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 65 years of age;&#xD;
&#xD;
          -  Clinical diagnosis of TBM;&#xD;
&#xD;
          -  Able and willing to provide informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Using any other second line antituberculosis drug;&#xD;
&#xD;
          -  Received anti-tuberculosis therapy in the past 3 years；&#xD;
&#xD;
          -  Positive CSF Gram or India ink stain;&#xD;
&#xD;
          -  Received more than 14 days of anti-tuberculosis drugs for the current infection;&#xD;
&#xD;
          -  Known or suspected hypersensitivity to or unacceptable side effects from any oral&#xD;
             first line antituberculosis drug;&#xD;
&#xD;
          -  Plasma creatinine concentration was more than the upper limit of the normal range, or&#xD;
             the plasma bilirubin concentration was more than 2 times the upper limit of the normal&#xD;
             range, or the plasma alanine aminotransferase level was more than three times the&#xD;
             upper limit of the normal range;&#xD;
&#xD;
          -  Known or suspected pregnancy;&#xD;
&#xD;
          -  Known or suspected isoniazid and/or rifampin resistant;&#xD;
&#xD;
          -  Lack of consent；&#xD;
&#xD;
          -  Any participant for whom investigators judge this study is not appropriate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hongfei Duan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Chest Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hongfei Duan, MD</last_name>
    <phone>13520728402</phone>
    <email>duanhongfei@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lingling Shao, Master</last_name>
    <phone>15810187170</phone>
    <email>shaolinglinglky@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Chest Hospital affiliated to Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongfei Duan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jiamusi Infectious Disease Hospital</name>
      <address>
        <city>Jiamusi</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chao Qiu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jiangxi Provincial Chest Hospital</name>
      <address>
        <city>Nanchang</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qilong Zhang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zunyi Medical College affiliated Hospital</name>
      <address>
        <city>Zunyi</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianyong Zhang</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>January 28, 2021</last_update_submitted>
  <last_update_submitted_qc>January 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>N-Acetyltransferase Type 2 Genotype</keyword>
  <keyword>treatment</keyword>
  <keyword>Tuberculous Meningitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Tuberculosis, Meningeal</mesh_term>
    <mesh_term>Meningitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Isoniazid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03787940
org study id: 2018ZX10302302-004
nct id: NCT03787940
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The genetically polymorphic N-acetyltransferase type 2 (NAT2) is responsible for isoniazid
      metabolism, and rapid acetylators were associated with low concentrations of isoniazid based
      on previous studies. The investigators hypothesize that among rapid acetylators high dose
      isoniazid would result in lower rates of death and disability in patients with tuberculous
      meningitis than the rates with the standard regimen. The investigators recruited patients
      between the ages of 18 and 65 years with newly diagnosed TBM, then NAT2 genotype will be
      characterized by using High-Resolution Melting Kit (Zeesan Company, Xiamen). Participants
      with slow or intermediate acetylators will be administered with standard chemotherapy. For
      participants with rapid acetylators, patients were stratified at study entry according to the
      modified British Medical Research Council criteria (MRC grade), then randomly assigned in a
      1:1 ratio to receive either standard or with high dose isoniazid treatment. All patients
      received antituberculosis treatment, which consisted of isoniazid (standard dose or high
      dose), rifampin, pyrazinamide, ethambutol for 3 months, followed by isoniazid, rifampin and
      ethambutol at the same doses for an additional 9 months. All patients received adjunctive
      treatment with dexamethasone for the first 6 to 8 weeks of treatment. 338 participants with
      rapid acetylators were randomly assigned to group B (standard treatment) and group C (high
      dose isoniazid), respectively. At the same time, 338 participants with slow or intermediate
      acetylators were recruited to group A (standard treatment). The primary outcome was death or
      severe disability 12 months after enrollment. Secondary outcome measures were coma-clearance
      time, fever-clearance time, and difference of laboratory examination (protein concentration,
      chloride, glucose and white cell counts) of cerebrospinal fluid.
Tuberculous meningitis (TBM) is the most lethal form of tuberculosis, causing death or severe
      neurologic deficits in more than half of those affected in spite of antituberculosis
      chemotherapy. Among the first line drugs, isoniazid is the only bactericidal agent that
      easily crossed blood-brain barrier, achieving concentrations in cerebrospinal fluid (CSF)
      similar to those in serum. The genetically polymorphic N-acetyltransferase type 2 (NAT2) is
      responsible for isoniazid metabolism, and individuals can be classified as "rapid
      acetylators", "intermediate acetylators" or "slow acetylators" based on NAT2 genotyping.
      Rapid acetylators were associated with low concentrations of isoniazid based on previous
      studies. The investigators hypothesize that among rapid acetylators high dose isoniazid would
      result in lower rates of death and disability in patients with tuberculous meningitis than
      the rates with the standard regimen.

      The investigators recruited patients between the ages of 18 and 65 years with newly diagnosed
      TBM. Patients could not enter the trial if they have been using any other second line
      antituberculosis drug; if they had received anti-tuberculosis therapy in the past 3 years；if
      they have positive CSF Gram or India ink stain; if they have received more than 14 days of
      anti-tuberculosis drugs for the current infection; if they were known or suspected
      hypersensitivity to or unacceptable side effects from any oral first line antituberculosis
      drug; if the plasma creatinine concentration was more than the upper limit of the normal
      range, if the plasma bilirubin concentration was more than 2 times the upper limit of the
      normal range, or if the plasma alanine aminotransferase level was more than three times the
      upper limit of the normal range; if they were known or suspected pregnancy; if they were
      known or suspected isoniazid and/or rifampin resistant; if they were lack of consent； if they
      were any participant for whom investigators judge this study is not appropriated.

      Participants will be recruited from four sites in China, including Beijing Chest Hospital
      affiliated to Capital Medical University, Zunyi Medical College affiliated Hospital, Jiangxi
      Provincial Chest Hospital and Jiamusi Infectious Disease Hospital. All hospitals serve the
      local community and act as tertiary referral centers for patients with severe tuberculosis or
      infectious diseases in China.

      Written informed consent to participate in the study was obtained from all patients. Then
      NAT2 genotype will be characterized by using High-Resolution Melting Kit (Zeesan Company,
      Xiamen). Participants with slow or intermediate acetylators will be administered with
      standard chemotherapy (3 months HRZE followed by 9 months HRE). For participants with rapid
      acetylators, patients were stratified at study entry according to the modified British
      Medical Research Council criteria (MRC grade), then randomly assigned in a 1:1 ratio to
      receive either standard or high dose isoniazid treatment.

      All patients received antituberculosis treatment, which consisted of isoniazid (300 mg for
      standard treatment and 900 mg for high dose treatment), rifampin (450 mg for weight no more
      than 50 kg, 600 mg for weight more than 50 kg), pyrazinamide (1500 mg for weight no more than
      50 kg, 1750 mg for weight more than 50 kg), ethambutol (750 mg for weight no more than 50 kg,
      1000 mg for weight more than 50 kg) for 3 months, followed by isoniazid, rifampin and
      ethambutol at the same doses for an additional 9 months. All patients received adjunctive
      treatment with dexamethasone for the first 6 to 8 weeks of treatment, as recommend by British
      Infection Society.

      338 participants with rapid acetylators will be randomly assigned to group B (standard
      treatment) and group C (high dose isoniazid), respectively. The calculation assumes an
      overall mortality and severe disability of 50% vs. 70 % in the two arms, a power of 80% and a
      two-sided significance level of 5%. Randomization ration is 1:1. At the same time, 338
      participants with slow or intermediate acetylators were recruited to group A (standard
      treatment).

      The primary outcome was death or severe disability 12 months after enrollment. Secondary
      outcome measures were coma-clearance time, fever-clearance time, and difference of CSF
      laboratory examination (protein concentration, chloride, glucose and white cell counts) of
      cerebrospinal fluid after 3 months treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Number of Participants with death or severe disability
time frame: up to 12 months after enrollment
description: Number of Participants with death or severe disability 12 months after enrollment
measure: days for coma-clearance time
time frame: through study completion,up to 1 year
description: days for coma-clearance time through study completion
measure: days for fever-clearance time
time frame: through study completion,up to 1 year
description: days for fever-clearance time through study completion
measure: difference of CSF protein concentration
time frame: 3 months after enrollment
description: difference of CSF protein concentration (g/L)
measure: difference of CSF glucose concentration
time frame: 3 months after enrollment
description: difference of CSF glucose concentration (mmol/L)
measure: difference of CSF white cell counts
time frame: 3 months after enrollment
description: difference of CSF white cell counts (per milliliter)
measure: difference of CSF chloride concentration
time frame: 3 months after enrollment
description: difference of CSF chloride concentration (mmol/L)
arm group label: Standard INH for Non-rapid acetylators
arm group type: Active Comparator
description: Participant with slow or intermediate acetylators(one of N-Acetyltransferase Type 2 Genotype) administered with standard chemotherapy (3 months HRZE followed by 9 months HRE with standard dose isoniazid)
arm group label: Standard INH for rapid acetylators
arm group type: Active Comparator
description: Participant with rapid acetylators(one of N-Acetyltransferase Type 2 Genotype) administered with standard chemotherapy (3 months HRZE followed by 9 months HRE with standard dose isoniazid )
arm group label: High dose INH for rapid acetylators
arm group type: Experimental
description: Participant with rapid acetylators(one of N-Acetyltransferase Type 2 Genotype) administered with high dose isonized treatment (3 months HRZE followed by 9 months HRE with high dose isoniazid)
intervention type: Drug
intervention name: Isoniazid
description: standard dose isoniazid or high dose isoniazid for participants with rapid acetylators
arm group label: High dose INH for rapid acetylators
arm group label: Standard INH for Non-rapid acetylators
arm group label: Standard INH for rapid acetylators
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hongfei Duan, MD
role: Principal Investigator
affiliation: Beijing Chest Hospital
last name: Hongfei Duan, MD
phone: 13520728402
email: duanhongfei@hotmail.com
last name: Lingling Shao, Master
phone: 15810187170
email: shaolinglinglky@163.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Tuberculosis
mesh term: Tuberculosis, Meningeal
mesh term: Meningitis
mesh term: Isoniazid
sharing ipd: Undecided