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

NCT ID: NCT01317654

Last Updated: 2011-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

340 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-04-30

Brief Summary

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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

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Conditions

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Tuberculosis Meningitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Survivors of TBM trial 2001-2005

Observation

Intervention Type OTHER

Collection of mortality data at 5 years post trial

Interventions

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Observation

Collection of mortality data at 5 years post trial

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

Patients without informed consent
Minimum Eligible Age

1 Year

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

OTHER

Sponsor Role collaborator

Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam

OTHER

Sponsor Role collaborator

Oxford University Clinical Research Unit, Vietnam

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Estee Torok, MD

Role: PRINCIPAL_INVESTIGATOR

Oxford University Clinical Research Unit - Viet Nam

References

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Torok ME, Nguyen DB, Tran TH, Nguyen TB, Thwaites GE, Hoang TQ, Nguyen HD, Tran TH, Nguyen TC, Hoang HT, Wolbers M, Farrar JJ. Dexamethasone and long-term outcome of tuberculous meningitis in Vietnamese adults and adolescents. PLoS One. 2011;6(12):e27821. doi: 10.1371/journal.pone.0027821. Epub 2011 Dec 8.

Reference Type DERIVED
PMID: 22174748 (View on PubMed)

Other Identifiers

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ES

Identifier Type: -

Identifier Source: org_study_id

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