Identification of Correlates of Protection Against Shigel... | NCT01638039

Studies
Identification of Correlates of Protection Against Shigella and Enterotoxigenic Escherichia Coli Infections

NCT01638039

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Jul 11, 2012Estimated

Enrollment

330Estimated

Phase

Not Applicable

Conditions

Dysentery

Interventions

Laboratory Tests

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

Jul 2012

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

Jul 2012

Primary Completion Date

Jul 2016Estimated

Completion Date

Jul 2016Estimated

First Submitted Date

Jul 8, 2012

First Submission Date that Met QC Criteria

Jul 8, 2012

First Posted Date

Jul 11, 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

Jul 8, 2012

Last Update Posted Date

Jul 11, 2012Estimated

Name	Class
European Commission	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

The aim of this study is to accelerate the development of vaccine candidates against diarrheal diseases caused by Shigella and Enterotoxigenic Escherichia coli (ETEC). We plan to identify cases of laboratory-proven shigellosis and ETEC-associated diarrhea, to study humoral and cellular immune parameters following natural infections with Shigella and ETEC, and to compare the level of pre-existing local, humoral and cellular immune parameters in cases of shigellosis and ETEC-associated diarrhea and in matched controls.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

330Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diarrheal disease	Active Comparator		Other: Laboratory Tests
Control	Active Comparator	Samples of stool, blood, urine saliva	Other: Laboratory Tests

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laboratory Tests	Other	Stool, blood, urine and saliva samples	Control Diarrheal disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identification of cases of shigellosis and ETEC-associated diarrhea	Stool of patients examined in laboratory and identified as infected with the pathogens	Four years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Lab-confirmed Shigella or ETEC
Individuals or patients without diarrheal disease

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Cohen, MPH, PhD	School of Public Health, Sackler Faculty of Medicine, Tel Aviv University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leumit Health Care System		Petach Tikvah	Elad	40800	Israel
Emek Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D004403	Dysentery

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019411	Clinical Laboratory Techniques

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided