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

• Sponsor: Hillel Yaffe Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01638039
• Collaborator: European Commission (Other)
• Enrollment: 330
• Locations: 7
• Arms: 2
• Duration (Months): 48
• Patients Per Site: 47.1
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dysentery	Other: Laboratory Tests	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 330 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Study Start Date: Jul 1, 2012
• Anticipated Primary Completion Date: Jul 1, 2016
• Anticipated Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Identification of cases of shigellosis and ETEC-associated diarrhea [Four years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Lab-confirmed Shigella or ETEC

• Individuals or patients without diarrheal disease

Exclusion Criteria:

• n/a

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leumit Health Care System	Petach Tikvah	Elad	Israel	40800
2	Emek Medical Center	Afula		Israel	18101
3	Hillel Yaffe Medical Center	Hadera		Israel	38100
4	Lady Davis Carmel Medical Center	Haifa		Israel	34362
5	Edith Wolfson Medical Center	Holon		Israel	58100
6	Sansz Medical Center - Laniado Hospital	Netanya		Israel	42150
7	Schneider Children's Medical Center	Petach Tikva		Israel	49202

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hillel Yaffe Medical Center
• ClinicalTrials.gov Identifier: NCT01638039
• Other Study ID Numbers: 0105-11-HYMC
• First Posted: Jul 11, 2012
• Last Update Posted: Jul 11, 2012
• Last Verified: Jul 1, 2012

• Additional relevant MeSH terms: Dysentery

Study Results

No Results Posted as of Jul 11, 2012