NCT01638039

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 11, 2012

Status Verified

July 1, 2012

Enrollment Period

4 years

First QC Date

July 8, 2012

Last Update Submit

July 8, 2012

Conditions

Dysentery

Outcome Measures

Primary Outcomes (1)

  • Identification of cases of shigellosis and ETEC-associated diarrhea

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

    Four years

Study Arms (2)

Diarrheal disease

ACTIVE COMPARATOR
Other: Laboratory Tests

Control

ACTIVE COMPARATOR

Samples of stool, blood, urine saliva

Other: Laboratory Tests

Interventions

Laboratory TestsOTHER

Stool, blood, urine and saliva samples

ControlDiarrheal disease

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Leumit Health Care System

Petach Tikvah, Elad, 40800, Israel

Location

Emek Medical Center

Afula, 18101, Israel

Location

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Lady Davis Carmel Medical Center

Haifa, 34362, Israel

Location

Edith Wolfson Medical Center

Holon, 58100, Israel

Location

Sansz Medical Center - Laniado Hospital

Netanya, 42150, Israel

Location

Schneider Children's Medical Center

Petah Tikva, 49202, Israel

Location

MeSH Terms

Conditions

Dysentery

Interventions

Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Daniel Cohen, MPH, PhD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2012

First Posted

July 11, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 11, 2012

Record last verified: 2012-07

Locations

IL(7)