Follow up of Autoantibodies in Active Tuberculosis | NCT00551226

Studies
Follow up of Autoantibodies in Active Tuberculosis

NCT00551226

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Oct 30, 2007Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Tuberculosis

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

Oct 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

Oct 27, 2007

First Submission Date that Met QC Criteria

Oct 29, 2007

First Posted Date

Oct 30, 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

Oct 29, 2007

Last Update Posted Date

Oct 30, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

We have previoulsy shown that patients with active Tuberculosis develop a wide array of autoantibodies including rheumatoid factor, anti-CCP, Antinuclear facyor and anti Sm antibodies. The purpose of this study is to evaluate whether the level of autoantibodies decrease after treatment aganist tuberculosis.

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients with tuberculosis
2		Healthy controls

Interventions

Not provided

Measure	Description	Time Frame
Follow up after levels of autoantibodies		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Active Tuberculosis treated

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed with active tuberculosis who are currently receiving anti tuberculosis drugs

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ori Elkayam, M.D	Contact	97236973668		oribe14@netvision.net.il

Overall Officials

Name	Affiliation	Role
Ori Elkayam, M.D	Tel Aviv Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tel Aviv Medical Center		Tel Aviv	Tel Aviv	64239	Israel

Condition Browse Module

MeSH Terms

ID	Term
D014376	Tuberculosis

Ancestor Terms

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided