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

This study has been completed.
Sponsor:
Collaborators:
Hospital for Tropical Diseases, Ho Chi Minh City, Viet Nam
Pham Ngoc Thach Hospital, Ho Chi Minh City Viet Nam
Information provided by (Responsible Party):
Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier:
NCT01317654
First received: March 16, 2011
Last updated: September 14, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention
Tuberculosis Meningitis
 Other: Observation

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oxford University Clinical Research Unit, Vietnam:

Primary Outcome Measures:
  • Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurological disability [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Tuberculosis relapse rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 340
Study Start Date: April 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Survivors of TBM trial 2001-2005 Other: Observation
Collection of mortality data at 5 years post trial

  Eligibility

Ages Eligible for Study:   1 Year to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Survivors of TBM trial 2001-2005

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317654

Sponsors and Collaborators
Oxford University Clinical Research Unit, Vietnam
Hospital for Tropical Diseases, Ho Chi Minh City, Viet Nam
Pham Ngoc Thach Hospital, Ho Chi Minh City Viet Nam
Investigators
Principal Investigator: Estee Torok, MD Oxford University Clinical Research Unit - Viet Nam
  More Information

No publications provided by Oxford University Clinical Research Unit, Vietnam

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier: NCT01317654     History of Changes
Other Study ID Numbers: ES
Study First Received: March 16, 2011
Last Updated: September 14, 2011
Health Authority: Vietnam: Department of Health of Ho Chi Minh City

Keywords provided by Oxford University Clinical Research Unit, Vietnam:
Tuberculosis meningitis

Additional relevant MeSH terms:
Meningitis
Tuberculosis
Tuberculosis, Meningeal
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Tuberculosis, Central Nervous System
Dexamethasone acetate
Dexamethasone
 Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on May 16, 2013