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
Sponsored by
About this trial
This is an interventional prevention trial for Dysentery
Eligibility Criteria
Inclusion Criteria:
- Lab-confirmed Shigella or ETEC
- Individuals or patients without diarrheal disease
Exclusion Criteria:
- n/a
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
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
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
Email
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
Email
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
Email
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
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