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

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ClinicalTrials.gov Identifier: NCT02588196
Recruitment Status : Unknown
Verified October 2015 by Hui Bu, Hebei Medical University.
Recruitment status was:  Not yet recruiting
First Posted : October 27, 2015
Last Update Posted : October 29, 2015
Sponsor:
Information provided by (Responsible Party):
Hui Bu, Hebei Medical University

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2015
Estimated Primary Completion Date : October 2018


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



Primary Outcome Measures :
  1. MRI [ Time Frame: 6 month ]
    whether MRI show infarction, hydrocephalus, meningeal enhancement

  2. changes of cerebrospinal fluid [ Time Frame: 1 year ]
  3. changes of clinical symptoms [ Time Frame: 1 year ]
    headache duration, duration of fever,presence of cranial nerve damage



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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Responsible Party: Hui Bu, chief physician, Hebei Medical University
ClinicalTrials.gov Identifier: NCT02588196     History of Changes
Other Study ID Numbers: BH 002
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Meningitis
Tuberculosis
Tuberculosis, Meningeal
Central Nervous System Diseases
Nervous System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Tuberculosis, Central Nervous System
Central Nervous System Infections
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action