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The Relationships Between Gene Polymorphisms of LTA4H and Dexamethasone Treatment for Tuberculous Meningitis

Primary Purpose

Tuberculous Meningitis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexamethasone acetate
Sponsored by
Hui Bu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tuberculous Meningitis

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

patients were eligible to enter the study if they met the diagnositic criteria for possible, probable or definite Tuberculosis meningitis(TBM).

Exclusion Criteria:

Patients were excluded if they were infected with HIV, diagnosed as carcinomatous meningitis, viral meningitis, purulent meningitis, cryptococcus meningitis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    treatment of dexamethasone group

    Arm Description

    Outcomes

    Primary Outcome Measures

    MRI
    whether MRI show infarction, hydrocephalus, meningeal enhancement
    changes of cerebrospinal fluid
    changes of clinical symptoms
    headache duration, duration of fever,presence of cranial nerve damage

    Secondary Outcome Measures

    Full Information

    First Posted
    October 26, 2015
    Last Updated
    October 27, 2015
    Sponsor
    Hui Bu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02588196
    Brief Title
    The Relationships Between Gene Polymorphisms of LTA4H and Dexamethasone Treatment for Tuberculous Meningitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    October 2018 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Hui Bu

    4. Oversight

    5. Study Description

    Brief Summary
    The study aimed to evaluate the relationships between the gene polymorphisms of leukotriene A4 hydrolase(LTA4H) and Dexamethasone treatment for tuberculous meningitis in Chinese patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tuberculous Meningitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment of dexamethasone group
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone acetate
    Primary Outcome Measure Information:
    Title
    MRI
    Description
    whether MRI show infarction, hydrocephalus, meningeal enhancement
    Time Frame
    6 month
    Title
    changes of cerebrospinal fluid
    Time Frame
    1 year
    Title
    changes of clinical symptoms
    Description
    headache duration, duration of fever,presence of cranial nerve damage
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Eligibility Criteria
    Inclusion Criteria: patients were eligible to enter the study if they met the diagnositic criteria for possible, probable or definite Tuberculosis meningitis(TBM). Exclusion Criteria: Patients were excluded if they were infected with HIV, diagnosed as carcinomatous meningitis, viral meningitis, purulent meningitis, cryptococcus meningitis.

    12. IPD Sharing Statement

    Learn more about this trial

    The Relationships Between Gene Polymorphisms of LTA4H and Dexamethasone Treatment for Tuberculous Meningitis

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