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

Brief Title

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

Official Title

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

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.
    



Study Type

Observational


Primary Outcome

Survival

Secondary Outcome

 Neurological disability

Condition

Tuberculosis Meningitis

Intervention

Observation

Study Arms / Comparison Groups

 Survivors of TBM trial 2001-2005
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

340

Start Date

April 2006

Completion Date

April 2008

Primary Completion Date

April 2008

Eligibility Criteria

        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
      

Gender

All

Ages

1 Year - 90 Years

Accepts Healthy Volunteers

No

Contacts

Estee Torok, MD, , 



Administrative Informations


NCT ID

NCT01317654

Organization ID

ES


Responsible Party

Sponsor

Study Sponsor

Oxford University Clinical Research Unit, Vietnam

Collaborators

 Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

Study Sponsor

Estee Torok, MD, Principal Investigator, Oxford University Clinical Research Unit - Viet Nam


Verification Date

September 2011