Study Of The Long Term Outcome Of Tuberculous Meningitis In Vietnamese Adults Treated With Adjunctive Dexamethasone

Completed

• Conditions: Tuberculosis Meningitis
• Interventions: Other: Observation

• Registration Number: NCT01317654
• Lead Sponsor: Oxford University Clinical Research Unit, Vietnam

Brief Summary

All patients who were alive at the end of the dexamethasone treatment trial conducted by Oxford University CLinical Research Unit from 2001-2005 (n=340) will be eligible to participate in this long-term follow-up study.

All eligible and consenting patients will undergo an assesment consisting of a simple questionnaire, a clinical examination and a blood test. Data collected will focus on survival, neurological disability and tuberculosis relapse. Data will be collected in individual case record forms and entered into a computer database.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Study First Submitted: 2011-03-16
• Study First Submitted QC: 2011-03-16
• Study First Posted: 2011-03-17
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-14
• Last Update Posted: 2011-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

Patients were alive at the end of the dexamethasone study (n=340) will be eligible to participate in this long-term follow-up study Informed consent

Exclusion Criteria

Patients without informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Survivors of TBM trial 2001-2005	Observation	-

Primary Outcome Measures

Name	Time	Method
Survival	5 years

Secondary Outcome Measures

Name	Time	Method
Neurological disability	5 years
Tuberculosis relapse rate	5 years