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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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:


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:

  • n/a
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Escherichia coli Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 16, 2014