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

This study is not yet open for participant recruitment.

Verified July 2012 by Hillel Yaffe Medical Center

Sponsor:

Collaborator:

European Commission

Information provided by (Responsible Party):

Hillel Yaffe Medical Center

ClinicalTrials.gov Identifier:

NCT01638039

First received: July 8, 2012

Last updated: NA

Last verified: July 2012

History: No changes posted

Purpose

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.

Condition	Intervention
Dysentery	Other: Laboratory Tests

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea E. Coli Infections

U.S. FDA Resources

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:

Identification of cases of shigellosis and ETEC-associated diarrhea [ Time Frame: Four years ] [ Designated as safety issue: No ]
Stool of patients examined in laboratory and identified as infected with the pathogens

Estimated Enrollment:	330
Study Start Date:	July 2012
Estimated Study Completion Date:	July 2016
Estimated Primary Completion Date:	July 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Diarrheal disease	Other: Laboratory Tests Stool, blood, urine and saliva samples
Active Comparator: Control Samples of stool, blood, urine saliva	Other: Laboratory Tests Stool, blood, urine and saliva samples

Eligibility

Ages Eligible for Study:	up to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01638039

Locations

Israel
Leumit Health Care System
Petach Tikvah, Elad, Israel, 40800
Emek Medical Center
Afula, Israel, 18101
Hillel Yaffe Medical Center	Not yet recruiting
Hadera, Israel, 38100
Contact: Amit Hochberg, MD 972-4-6304331 amit.hochberg@gmail.com
Lady Davis Carmel Medical Center	Not yet recruiting
Haifa, Israel, 34362
Contact: Moshe Efrat, MD 972-4-8250354
Edith Wolfson Medical Center
Holon, Israel, 58100
Sansz Medical Center - Laniado Hospital	Not yet recruiting
Netanya, Israel, 42150
Contact: Uri Rubinstein, MD 972-9-8604677 urirubinst@gmail.com
Schneider Children's Medical Center	Not yet recruiting
Petach Tikva, Israel, 49202
Contact: Shai Ashkenazi, MD 972-3-9253137 sashkenazi@clalit.gov.il

Sponsors and Collaborators

Hillel Yaffe Medical Center

European Commission

Investigators

Study Director:

Daniel Cohen, MPH, PhD

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

More Information

No publications provided

Responsible Party:	Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:	NCT01638039 History of Changes
Other Study ID Numbers:	0105-11-HYMC
Study First Received:	July 8, 2012
Last Updated:	July 8, 2012
Health Authority:	Israel: Ministry of Health

Additional relevant MeSH terms:

Dysentery
Escherichia coli Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

Intestinal Diseases
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 23, 2013

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