Autoantibodies Against Specific Cytokines in Adults With... | NCT01628744

Studies
Autoantibodies Against Specific Cytokines in Adults With Severe Mycobacterial Infection

NCT01628744

Sponsor

China Medical University Hospital

Status

Unknown status

Last Update Posted

Jun 27, 2012Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Mycobacterium Infection

Interventions

Not provided

Countries

Taiwan

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

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Not provided

Completion Date

Dec 2014Estimated

First Submitted Date

Jun 24, 2012

First Submission Date that Met QC Criteria

Jun 26, 2012

First Posted Date

Jun 27, 2012Estimated

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

Jun 26, 2012

Last Update Posted Date

Jun 27, 2012Estimated

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

In adult, the prevalence of mycobacterial infections is increased with age is largely unknown. IFN-gamma-IL-12/23 axis or NF-kappaB pathways might also plays crucial roles in adult against mycobacteria. Based on this hypothesis, the investigators had applied a functional assay to these pathways in patients with mycobacterial infection.

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

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
Patients with mycobacterial infection

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with mycobacterial infection

Exclusion Criteria:

Malignancy
Severe autoimmune
HIV infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Pateitns with Mycobacterium, Particular to the non Tuberculosis mycobacterium infection, in Taiwan

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cheng-?Lung KU, Ph.D	Contact	(886) (0)3 211-8800	3496	clku@mail.cgu.edu.tw

Overall Officials

Name	Affiliation	Role
Cheng-Lung KU, Ph.D	Graduate Institute of clinical Medical Science, China Medical Univerity, Taiwan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Graduate Institute of Clinical Medical Science, China Medical University	Recruiting	Taichung			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D009164	Mycobacterium Infections

Ancestor Terms

ID	Term
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

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