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

October 27, 2015 updated by: Hui Bu
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI
Time Frame: 6 month
whether MRI show infarction, hydrocephalus, meningeal enhancement
6 month
changes of cerebrospinal fluid
Time Frame: 1 year
1 year
changes of clinical symptoms
Time Frame: 1 year
headache duration, duration of fever,presence of cranial nerve damage
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hui Bu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 27, 2015

Study Record Updates

Last Update Posted (Estimate)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 27, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BH 002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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