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

Tuberculosis Meningitis Clinical Trial

— ES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317654
• Other study ID #: ES
• Status: Completed
• Phase: N/A
• First received: March 16, 2011
• Last updated: September 14, 2011
• Start date: April 2006
• Est. completion date: April 2008

Study information

• Verified date: September 2011
• Source: Oxford University Clinical Research Unit, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Department of Health of Ho Chi Minh City
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 90 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Meningitis
• Tuberculosis
• Tuberculosis Meningitis
• Tuberculosis, Meningeal

Intervention

Other:
• Observation
Collection of mortality data at 5 years post trial

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Oxford University Clinical Research Unit, Vietnam	Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		5 years	No
Secondary	Neurological disability		5 years	No
Secondary	Tuberculosis relapse rate		5 years	No