Tuberculosis MeningitisESNCT01317654
Study Of The Long Term Outcome Of Tuberculous Meningitis In Vietnamese Adults Treated With Adjunctive Dexamethasone
An observational study of Tuberculosis Meningitis, run by Oxford University Clinical Research Unit, Vietnam.
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. Read more about this study
- Who is it for?
- Ages 1 year to 90 years
- Conditions the study is for
- Tuberculosis Meningitis
- What is being tested?
- Observation
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Apr 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Survivors of TBM trial 2001-2005
Who may be able to join
None listed.
Who cannot join
- Patients without informed consent
About this study
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.
- Conditions
- Tuberculosis Meningitis
- Being tested
- Observation
- Keywords
- Tuberculosis meningitis
- Medical subject headings
- Tuberculosis, Meningeal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Collection of mortality data at 5 years post trial
| Study group | Role | What they receive |
|---|---|---|
| Survivors of TBM trial 2001-2005 | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 5 years
Secondary outcomes (2)
Neurological disability
Measured: 5 years
Tuberculosis relapse rate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startApr 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis MeningitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam
- Responsible party
- Sponsor
- Investigators
- Estee Torok, MD, Principal investigator, Oxford University Clinical Research Unit - Viet Nam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317654
- Sponsor's protocol ID
- ES
- Acronym
- ES
- Status last verified
- Sep 2011
- First submitted
- 16 Mar 2011
- Last updated
- 15 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Torok ME, Nguyen DB, Tran TH, Nguyen TB, Thwaites GE, Hoang TQ, Nguyen HD, Tran TH, Nguyen TC, Hoang HT, Wolbers M, Farrar JJ. Dexamethasone and long-term outcome of tuberculous meningitis in Vietnamese adults and adolescents. PLoS One. 2011;6(12):e27821. doi: 10.1371/journal.pone.0027821. Epub 2011 Dec 8.
PubMed 22174748
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Of The Long Term Outcome Of Tuberculous Meningitis In Vietnamese Adults Treated With Adjunctive Dexamethasone
- ClinicalTrials.gov ID
- NCT01317654
- Acronym / sponsor ID
- ES / ES
- Conditions
- Tuberculosis Meningitis
- Keywords
- Tuberculosis meningitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Collaborators
- Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam
- Study start
- Apr 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 17 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survivors of TBM trial 2001-2005 | – | Other: Observation |
Who may qualify
- Ages
- 1 year to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Survivors of TBM trial 2001-2005
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients without informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationCollection of mortality data at 5 years post trial | Other | Survivors of TBM trial 2001-2005 |
Primary outcome
Survival
Time frame: 5 years
2 secondary outcomes
Neurological disability
Time frame: 5 years
Tuberculosis relapse rate
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2011.
- Derived from this study: PubMed 22174748Torok ME, Nguyen DB, Tran TH, Nguyen TB, Thwaites GE, Hoang TQ, Nguyen HD, Tran TH, Nguyen TC, Hoang HT, Wolbers M, Farrar JJ. Dexamethasone and long-term outcome of tuberculous meningitis in Vietnamese adults and adolescents. PLoS One. 2011;6(12):e27821. doi: 10.1371/journal.pone.0027821. Epub 2011 Dec 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Estee Torok, MD principal investigator
Oxford University Clinical Research Unit - Viet Nam
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis Meningitis, run by Oxford University Clinical Research Unit, Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01317654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2011.