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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01317654
Recruitment Status : Completed
First Posted : March 17, 2011
Last Update Posted : September 15, 2011
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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
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 : April 2006
Primary Completion Date : April 2008
Study Completion Date : April 2008


Groups and Cohorts

Group/Cohort 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 [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Neurological disability [ Time Frame: 5 years ]
  2. Tuberculosis relapse rate [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317654


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
More Information

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
First Posted: March 17, 2011    Key Record Dates
Last Update Posted: September 15, 2011
Last Verified: September 2011

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

Additional relevant MeSH terms:
Tuberculosis
Meningitis
Tuberculosis, Meningeal
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Tuberculosis, Central Nervous System
Central Nervous System Infections
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action