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NCT01638039 Clinical Trial

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

Dysentery Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01638039
Other study ID # 0105-11-HYMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 8, 2012
Last updated July 8, 2012
Start date July 2012
Est. completion date July 2016

Study information
Verified date July 2012
Source Hillel Yaffe Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 330
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 65 Years
Eligibility Inclusion Criteria:

- Lab-confirmed Shigella or ETEC

- Individuals or patients without diarrheal disease

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• Laboratory Tests
Stool, blood, urine and saliva samples

Locations
Country Name City State
Israel Emek Medical Center Afula
Israel Hillel Yaffe Medical Center Hadera
Israel Lady Davis Carmel Medical Center Haifa
Israel Edith Wolfson Medical Center Holon
Israel Sansz Medical Center - Laniado Hospital Netanya
Israel Schneider Children's Medical Center Petach Tikva
Israel Leumit Health Care System Petach Tikvah Elad

Sponsors (2)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center European Commission

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of cases of shigellosis and ETEC-associated diarrhea Stool of patients examined in laboratory and identified as infected with the pathogens Four years No
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