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
About this trial
This is an interventional treatment trial for Tuberculous Meningitis
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.
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
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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