NCT00807378

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

May 20, 2010

Status Verified

May 1, 2010

Enrollment Period

1.4 years

First QC Date

December 9, 2008

Last Update Submit

May 19, 2010

Conditions

Keywords

CNS viral infectionPCRHYBRIDIZATION

Study Arms (2)

1

AIDS PATIENTS

Other: LUMBAR PUNCTURE

2

NON-AIDS PATIENTS

Other: LUMBAR PUNCTURE

Interventions

LUMBAR PUNCTURE FFOR CSF COLLECTION

12

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CNS VIRAL INFECTION AIDS/NON-AIDS

You may qualify if:

  • AGE MORE THAN 15 YRS
  • ABLE TO INFORM CONSENT BY THEMSELF OR THEIR PARENT
  • SUSPECTED CNS VIRAL INFECTION

You may not qualify if:

  • UNABLE/CONTRAINDICATED FOR LUMBAR PUNCTURE OR CSF COLLECTION
  • WITHDRAW CONSENT
  • SUSPECTED SEVERE OR VILURENT VIRAL INFECTION SUCH AS H5N1/SARS INFECTION

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

CSF DNA/RNA virus

MeSH Terms

Conditions

Central Nervous System Viral Diseases

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

Central Nervous System InfectionsInfectionsVirus DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

BiopsySpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 9, 2008

First Posted

December 11, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

May 20, 2010

Record last verified: 2010-05