Autoantibodies and Clinical Symptoms in Infective Endocar... | NCT00562653

Studies
Autoantibodies and Clinical Symptoms in Infective Endocarditis Patients

NCT00562653

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Nov 22, 2007Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Infective Endocarditis

Interventions

Not provided

Countries

Israel

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

Nov 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Not provided

Completion Date

Nov 2008Estimated

First Submitted Date

Nov 20, 2007

First Submission Date that Met QC Criteria

Nov 21, 2007

First Posted Date

Nov 22, 2007Estimated

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

Nov 21, 2007

Last Update Posted Date

Nov 22, 2007Estimated

Name	Class
Ministry of Health, Israel	OTHER_GOV

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

The purpose is to evaluate autoantibodies in infective endocarditis patients before, at the beginning of treatment, and after the end of the treatment, and to correlate the autoantibodies in the presence of clinical symptoms.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		infective endocarditis patients before treatment
2		infective endocarditis treatment after treatment
3		control

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infective endocarditis patients by DUKES criteria

Exclusion Criteria:

HIV positive
Patients suffering from other infective diseases other than endocarditis.
Patient suffering from collagen diseases for example: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), mixed connective tissue disease, and scleroderma.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

infective endocarditis patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Victoria Bogusllavsky, MD	Sourasky Medical Center, Internal Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sourasky Medical Center		Tel Aviv			Israel

Condition Browse Module

MeSH Terms

ID	Term
D004696	Endocarditis

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided