CNS Viral InfectionVIMPACNCT00807378
Rijavithi Viral and Mycobacterium PCR Arrays in CNS Infection Study
An observational study of CNS Viral Infection, run by Department of Medical Services Ministry of Public Health of Thailand.
Trial summary
This study of neurotropic viral infection and Tuberculous CNS infection is the comprehensive investigation of CSF PCR arrays (Hybrydiaztion technique,Sybergreen and Taqman real time PCR arrays of CSF ) in suspected cases of viral CNS infection, Tuberculous CNS infection in both AIDS and non AIDS patients. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- CNS Viral Infection
- What is being tested?
- LUMBAR PUNCTURE
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Mar 2010
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: CNS VIRAL INFECTION AIDS/NON-AIDS
Who may be able to join
- AGE MORE THAN 15 YRS
- ABLE TO INFORM CONSENT BY THEMSELF OR THEIR PARENT
- SUSPECTED CNS VIRAL INFECTION
Who cannot join
- UNABLE/CONTRAINDICATED FOR LUMBAR PUNCTURE OR CSF COLLECTION
- WITHDRAW CONSENT
- SUSPECTED SEVERE OR VILURENT VIRAL INFECTION SUCH AS H5N1/SARS INFECTION
About this study
Official title: Cerebrospinal Fluid Polymerase Chain Reaction Arrays for Central Nervous System Neurotropic Viral Infection and Mycobacterium Infection Study
This study of neurotropic viral infection and Tuberculous CNS infection is the comprehensive investigation of CSF PCR arrays (Hybrydiaztion technique,Sybergreen and Taqman real time PCR arrays of CSF ) in suspected cases of viral CNS infection, Tuberculous CNS infection in both AIDS and non AIDS patients.
Patients with clinical viral encephalitis and all meningoencephalitis including all patients with HIV/AIDS CSF and non AIDS will be banked and test for RNA and DNA viral sequence by Real time PCR arrays and IS6110 gene of Mycobacterium tuberculosis. Clinical data and final diagnosis will be used to analyze the result of this PCR arrays technique compared to clinical gold standard criteria.
- Conditions
- CNS Viral Infection
- Being tested
- LUMBAR PUNCTURE
- Keywords
- CNS viral infection, PCR, HYBRIDIZATION
- Medical subject headings
- Central Nervous System Viral Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUMBAR PUNCTUREOther
LUMBAR PUNCTURE FFOR CSF COLLECTION
| Study group | Role | What they receive |
|---|---|---|
| 1 | AIDS PATIENTS Receives: Other: LUMBAR PUNCTURE | |
| 2 | NON-AIDS PATIENTS Receives: Other: LUMBAR PUNCTURE |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CNS Viral InfectionStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Collaborators
- Rajavithi Biomolecular Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807378
- Sponsor's protocol ID
- RH-CMR-004
- Acronym
- VIMPAC
- Status last verified
- May 2010
- First submitted
- 9 Dec 2008
- Last updated
- 20 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrospinal Fluid Polymerase Chain Reaction Arrays for Central Nervous System Neurotropic Viral Infection and Mycobacterium Infection Study
- ClinicalTrials.gov ID
- NCT00807378
- Acronym / sponsor ID
- VIMPAC / RH-CMR-004
- Conditions
- CNS Viral Infection
- Keywords
- CNS viral infection, PCR, HYBRIDIZATION
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Collaborators
- Rajavithi Biomolecular Research Center
- Study start
- Jul 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 11 Dec 2008 (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.
This study of neurotropic viral infection and Tuberculous CNS infection is the comprehensive investigation of CSF PCR arrays (Hybrydiaztion technique,Sybergreen and Taqman real time PCR arrays of CSF ) in suspected cases of viral CNS infection, Tuberculous CNS infection in both AIDS and non AIDS patients.
Patients with clinical viral encephalitis and all meningoencephalitis including all patients with HIV/AIDS CSF and non AIDS will be banked and test for RNA and DNA viral sequence by Real time PCR arrays and IS6110 gene of Mycobacterium tuberculosis. Clinical data and final diagnosis will be used to analyze the result of this PCR arrays technique compared to clinical gold standard criteria.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: LUMBAR PUNCTUREAIDS PATIENTS |
| 2 | – | Other: LUMBAR PUNCTURENON-AIDS PATIENTS |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CNS VIRAL INFECTION AIDS/NON-AIDS
Key inclusion criteria (3 listed)
- AGE MORE THAN 15 YRS
- ABLE TO INFORM CONSENT BY THEMSELF OR THEIR PARENT
- SUSPECTED CNS VIRAL INFECTION
Key exclusion criteria (3 listed)
- UNABLE/CONTRAINDICATED FOR LUMBAR PUNCTURE OR CSF COLLECTION
- WITHDRAW CONSENT
- SUSPECTED SEVERE OR VILURENT VIRAL INFECTION SUCH AS H5N1/SARS INFECTION
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 |
|---|---|---|
| LUMBAR PUNCTURELUMBAR PUNCTURE FFOR CSF COLLECTION | Other | 1, 2 |
Primary outcome
Not reported in the source record.
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 20 May 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of CNS Viral Infection, run by Department of Medical Services Ministry of Public Health of Thailand.
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 3 inclusion and 3 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 20 May 2010. 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.
Where can I read the original study information?
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 20 May 2010.