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OpenTrials
Completed

NCT Number: NCT01317654

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

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.

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Key information

Conditions

Tuberculosis Meningitis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Gram-Positive Bacterial Infections Infections Meningitis Meningitis, Bacterial Mycobacterium Infections Nervous System Diseases Neuroinflammatory Diseases Tuberculosis Tuberculosis, Central Nervous System Tuberculosis, Extrapulmonary Tuberculosis, Meningeal

Age range

1 year–90 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

Collection of mortality data at 5 years post trial

Primary outcomes

  1. Survival

    Time frame: 5 years

Secondary outcomes

  1. Neurological disability

    Time frame: 5 years

  2. Tuberculosis relapse rate

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Oxford University Clinical Research Unit, Vietnam

Other

Collaborators

  • Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
  • Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam

Registry information

Acronym: ES

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 17, 2011
Registry last updated
Sep 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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