DysenteryNCT01638039
Identification of Correlates of Protection Against Shigella and Enterotoxigenic Escherichia Coli Infections
A study testing Laboratory Tests in people with Dysentery, run by Hillel Yaffe Medical Center at 7 sites in Israel.
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… Read more about this study
- Who is it for?
- Ages Up to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysentery
- What is being tested?
- Laboratory Tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 7 sitesIsrael
- Study dates
- Jul 2012to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Lab-confirmed Shigella or ETEC
- Individuals or patients without diarrheal disease
Who cannot join
- n/a
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Israel7 sites
Emek Medical Center
Afula, 18101
Hillel Yaffe Medical Center
Hadera, 38100
Amit Hochberg, MD, 972-4-6304331, amit.hochberg@gmail.com
Lady Davis Carmel Medical Center
Haifa, 34362
Moshe Efrat, MD, 972-4-8250354
Edith Wolfson Medical Center
Holon, 58100
Sansz Medical Center - Laniado Hospital
Netanya, 42150
Uri Rubinstein, MD, 972-9-8604677, urirubinst@gmail.com
Leumit Health Care System
Petach Tikvah, Elad, 40800
Schneider Children's Medical Center
Petah Tikva, 49202
Shai Ashkenazi, MD, 972-3-9253137, sashkenazi@clalit.gov.il
About this study
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.
- Conditions
- Dysentery
- Being tested
- Laboratory Tests
- Medical subject headings
- Dysentery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory TestsOther
Stool, blood, urine and saliva samples
| Study group | Role | What they receive |
|---|---|---|
| Diarrheal disease | Active comparator | Not described Receives: Other: Laboratory Tests |
| Control | Active comparator | Samples of stool, blood, urine saliva Receives: Other: Laboratory Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of cases of shigellosis and ETEC-associated diarrhea
Stool of patients examined in laboratory and identified as infected with the pathogens
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysenteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- Daniel Cohen, MPH, PhD, Study director, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638039
- Sponsor's protocol ID
- 0105-11-HYMC
- Status last verified
- Jul 2012
- First submitted
- 8 Jul 2012
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Correlates of Protection Against Shigella and Enterotoxigenic Escherichia Coli Infections
- ClinicalTrials.gov ID
- NCT01638039
- Acronym / sponsor ID
- 0105-11-HYMC
- Conditions
- Dysentery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Collaborators
- European Commission
- Study start
- Jul 2012
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diarrheal disease | Active comparator | Other: Laboratory Tests |
| Control | Active comparator | Other: Laboratory TestsSamples of stool, blood, urine saliva |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Lab-confirmed Shigella or ETEC
- Individuals or patients without diarrheal disease
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory TestsStool, blood, urine and saliva samples | Other | Control, Diarrheal disease |
Primary outcome
Identification of cases of shigellosis and ETEC-associated diarrhea
Time frame: Four years
Stool of patients examined in laboratory and identified as infected with the pathogens
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Cohen, MPH, PhD study director
School of Public Health, Sackler Faculty of Medicine, Tel Aviv University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laboratory Tests in people with Dysentery, run by Hillel Yaffe Medical Center at 7 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of cases of shigellosis and ETEC-associated diarrhea (time frame: Four years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2012.