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Rijavithi Viral and Mycobacterium PCR Arrays in CNS Infection Study (VIMPAC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00807378
First Posted: December 11, 2008
Last Update Posted: May 20, 2010
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.
Collaborator:
Rajavithi Biomolecular Research Center
Information provided by:
Rajavithi Hospital
  Purpose

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.


Condition Intervention
CNS Viral Infection Other: LUMBAR PUNCTURE

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cerebrospinal Fluid Polymerase Chain Reaction Arrays for Central Nervous System Neurotropic Viral Infection and Mycobacterium Infection Study

Resource links provided by NLM:


Further study details as provided by Rajavithi Hospital:

Biospecimen Retention:   Samples With DNA
CSF DNA/RNA virus

Estimated Enrollment: 200
Study Start Date: July 2008
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
AIDS PATIENTS
Other: LUMBAR PUNCTURE
LUMBAR PUNCTURE FFOR CSF COLLECTION
2
NON-AIDS PATIENTS
Other: LUMBAR PUNCTURE
LUMBAR PUNCTURE FFOR CSF COLLECTION

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CNS VIRAL INFECTION AIDS/NON-AIDS
Criteria

Inclusion Criteria:

  1. AGE MORE THAN 15 YRS
  2. ABLE TO INFORM CONSENT BY THEMSELF OR THEIR PARENT
  3. SUSPECTED CNS VIRAL INFECTION

Exclusion Criteria:

  1. UNABLE/CONTRAINDICATED FOR LUMBAR PUNCTURE OR CSF COLLECTION
  2. WITHDRAW CONSENT
  3. SUSPECTED SEVERE OR VILURENT VIRAL INFECTION SUCH AS H5N1/SARS INFECTION
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Piyathida Harnsomboonrana, Rajavithi Biomolecular Research Center
ClinicalTrials.gov Identifier: NCT00807378     History of Changes
Other Study ID Numbers: RH-CMR-004
First Submitted: December 9, 2008
First Posted: December 11, 2008
Last Update Posted: May 20, 2010
Last Verified: May 2010

Keywords provided by Rajavithi Hospital:
CNS viral infection
PCR
HYBRIDIZATION

Additional relevant MeSH terms:
Infection
Communicable Diseases
Mycobacterium Infections
Virus Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections