Rijavithi Viral and Mycobacterium PCR Arrays in CNS Infec... | NCT00807378

Studies
Rijavithi Viral and Mycobacterium PCR Arrays in CNS Infection Study

NCT00807378

Sponsor

Department of Medical Services Ministry of Public Health of Thailand

Status

Completed

Last Update Posted

May 20, 2010Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

CNS Viral Infection

Interventions

LUMBAR PUNCTURE

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Mar 2010Actual

First Submitted Date

Dec 9, 2008

First Submission Date that Met QC Criteria

Dec 9, 2008

First Posted Date

Dec 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2010

Last Update Posted Date

May 20, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Department of Medical Services Ministry of Public Health of ThailandOTHER_GOV

Collaborators

Name	Class
Rajavithi Biomolecular Research Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		AIDS PATIENTS	Other: LUMBAR PUNCTURE
2		NON-AIDS PATIENTS	Other: LUMBAR PUNCTURE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LUMBAR PUNCTURE	Other	LUMBAR PUNCTURE FFOR CSF COLLECTION	1 2

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

CNS VIRAL INFECTION AIDS/NON-AIDS

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D020805	Central Nervous System Viral Diseases

Ancestor Terms

ID	Term
D002494	Central Nervous System Infections
D007239	Infections
D014777	Virus Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013129	Spinal Puncture

Ancestor Terms

ID	Term
D001706	Biopsy
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided