NCT02588196

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

2.9 years

First QC Date

October 26, 2015

Last Update Submit

October 27, 2015

Conditions

Tuberculous Meningitis

Outcome Measures

Primary Outcomes (3)

  • MRI

    whether MRI show infarction, hydrocephalus, meningeal enhancement

    6 month

  • changes of cerebrospinal fluid

    1 year

  • changes of clinical symptoms

    headache duration, duration of fever,presence of cranial nerve damage

    1 year

Study Arms (1)

treatment of dexamethasone group

EXPERIMENTAL
Drug: Dexamethasone acetate

Interventions

Dexamethasone acetateDRUG
treatment of dexamethasone group

Eligibility Criteria

Age14 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tuberculosis, Meningeal

Interventions

dexamethasone acetate

Condition Hierarchy (Ancestors)

Meningitis, BacterialCentral Nervous System Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsTuberculosis, Central Nervous SystemTuberculosis, ExtrapulmonaryTuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

October 26, 2015

First Posted

October 27, 2015

Study Start

November 1, 2015

Primary Completion

October 1, 2018

Last Updated

October 29, 2015

Record last verified: 2015-10