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

Sponsor

Hui Bu (Other)

Overall Status

Unknown status

CT.gov ID

NCT02588196

Collaborator

(none)

200

Enrollment

Arm

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tuberculous Meningitis	Drug: Dexamethasone acetate	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Nov 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treatment of dexamethasone group	Drug: Dexamethasone acetate

Arm

Intervention/Treatment

Experimental: treatment of dexamethasone group

Drug: Dexamethasone acetate

Outcome Measures

Primary Outcome Measures

MRI [6 month]
whether MRI show infarction, hydrocephalus, meningeal enhancement
changes of cerebrospinal fluid [1 year]
changes of clinical symptoms [1 year]
headache duration, duration of fever,presence of cranial nerve damage

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

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.