Back to results

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

Primary Purpose

Dysentery

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Laboratory Tests

About this trial

This is an interventional prevention trial for Dysentery

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Sites / Locations

Leumit Health Care System
Emek Medical Center
Hillel Yaffe Medical Center
Lady Davis Carmel Medical Center
Edith Wolfson Medical Center
Sansz Medical Center - Laniado Hospital
Schneider Children's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Diarrheal disease

Control

Arm Description

Samples of stool, blood, urine saliva

Outcomes

Primary Outcome Measures

Identification of cases of shigellosis and ETEC-associated diarrhea

Stool of patients examined in laboratory and identified as infected with the pathogens

Secondary Outcome Measures

Full Information

NCT ID

NCT01638039

First Posted

July 8, 2012

Last Updated

July 8, 2012

Sponsor

Hillel Yaffe Medical Center

Collaborators

European Commission

1. Study Identification

Unique Protocol Identification Number

NCT01638039

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Unknown status

Study Start Date

July 2012 (undefined)

Primary Completion Date

July 2016 (Anticipated)

Study Completion Date

July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hillel Yaffe Medical Center

Collaborators

European Commission

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dysentery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diarrheal disease

Arm Type

Active Comparator

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Samples of stool, blood, urine saliva

Intervention Type

Other

Intervention Name(s)

Laboratory Tests

Intervention Description

Stool, blood, urine and saliva samples

Primary Outcome Measure Information:

Title

Identification of cases of shigellosis and ETEC-associated diarrhea

Description

Stool of patients examined in laboratory and identified as infected with the pathogens

Time Frame

Four years

10. Eligibility

Sex

All

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Lab-confirmed Shigella or ETEC Individuals or patients without diarrheal disease Exclusion Criteria: n/a

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Cohen, MPH, PhD

Organizational Affiliation

School of Public Health, Sackler Faculty of Medicine, Tel Aviv University

Official's Role

Study Director

Facility Information:

Facility Name

Leumit Health Care System

City

Petach Tikvah

State/Province

Elad

ZIP/Postal Code

40800

Country

Israel

Facility Name

Emek Medical Center

City

Afula

ZIP/Postal Code

18101

Country

Israel

Facility Name

Hillel Yaffe Medical Center

City

Hadera

ZIP/Postal Code

38100

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amit Hochberg, MD

Phone

972-4-6304331

amit.hochberg@gmail.com

Facility Name

Lady Davis Carmel Medical Center

City

Haifa

ZIP/Postal Code

34362

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Moshe Efrat, MD

Phone

972-4-8250354

Facility Name

Edith Wolfson Medical Center

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

Sansz Medical Center - Laniado Hospital

City

Netanya

ZIP/Postal Code

42150

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Uri Rubinstein, MD

Phone

972-9-8604677

urirubinst@gmail.com

Facility Name

Schneider Children's Medical Center

City

Petach Tikva

ZIP/Postal Code

49202

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shai Ashkenazi, MD

Phone

972-3-9253137

sashkenazi@clalit.gov.il

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs