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

• Sponsor: Oxford University Clinical Research Unit, Vietnam (Other)
• Overall Status: Completed
• CT.gov ID: NCT01317654
• Collaborator: Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam (Other), Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (Other)
• Enrollment: 340
• Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis Meningitis	Other: Observation

Study Design

• Study Type: Observational
• Actual Enrollment: 340 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Study Of The Long Term Outcome Of Tuberculous Meningitis In Vietnamese Adults Treated With Adjunctive Dexamethasone
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Survivors of TBM trial 2001-2005	Other: Observation; Collection of mortality data at 5 years post trial

Outcome Measures

Primary Outcome Measures

1. Survival [5 years]

Secondary Outcome Measures

1. Neurological disability [5 years]

2. Tuberculosis relapse rate [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oxford University Clinical Research Unit, Vietnam
• ClinicalTrials.gov Identifier: NCT01317654
• Other Study ID Numbers: ES
• First Posted: Mar 17, 2011
• Last Update Posted: Sep 15, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by Oxford University Clinical Research Unit, Vietnam: Tuberculosis meningitis
• Additional relevant MeSH terms: Tuberculosis; Tuberculosis, Meningeal; Meningitis

Study Results

No Results Posted as of Sep 15, 2011