NCT01317654

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2006

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
Last Updated

September 15, 2011

Status Verified

September 1, 2011

Enrollment Period

2 years

First QC Date

March 16, 2011

Last Update Submit

September 14, 2011

Conditions

Tuberculosis Meningitis

Keywords

Tuberculosis meningitis

Outcome Measures

Primary Outcomes (1)

  • Survival

    5 years

Secondary Outcomes (2)

  • Neurological disability

    5 years

  • Tuberculosis relapse rate

    5 years

Study Arms (1)

Survivors of TBM trial 2001-2005

Other: Observation

Interventions

ObservationOTHER

Collection of mortality data at 5 years post trial

Survivors of TBM trial 2001-2005

Eligibility Criteria

Age1 Year - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Survivors of TBM trial 2001-2005

You may not qualify if:

  • Patients without informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 22174748DERIVED

MeSH Terms

Conditions

Tuberculosis, Meningeal

Interventions

Observation

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

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Estee Torok, MD

    Oxford University Clinical Research Unit - Viet Nam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 17, 2011

Study Start

April 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

September 15, 2011

Record last verified: 2011-09