Infectivity of Norovirus in Shellfish Treated With High Hydrostatic Pressure Processing-Human Challenge Study
This study has been completed.
Sponsor:
Emory University
Collaborator:
Virginia Polytechnic Institute and State University
Information provided by (Responsible Party):
Christine Moe, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00674336
First received: May 6, 2008
Last updated: March 30, 2012
Last verified: March 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 6, 2008 | ||||||||
| Last Updated Date | March 30, 2012 | ||||||||
| Start Date ICMJE | September 2007 | ||||||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Infection with norovirus [ Time Frame: Throughout participation in study ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00674336 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Infectivity of Norovirus in Shellfish Treated With High Hydrostatic Pressure Processing-Human Challenge Study | ||||||||
| Official Title ICMJE | Norwalk Virus Inactivation by High Hydrostatic Pressure Processing: A Comprehensive and Integrated Program for Research and Outreach | ||||||||
| Brief Summary | Norwalk virus and related "Norwalk-like viruses" are the most common cause of outbreaks of stomach sickness (nausea, vomiting, diarrhea) in older children and adults in the United States. These viruses are sometimes found in drinking water, ice, shellfish and in other foods. They can be spread easily from contact with water, food, objects or hands that have even small amounts of feces from someone who was sick. The purpose of this research study is to the effectiveness of high hydrostatic pressures processing (HPP) treatment on norovirus infected shellfish. Norwalk virus can survive in shellfish and still be able to cause sickness. HPP inactivates microorganisms living both on the surface and on the interior of the food. The goal of the study is to determine whether HPP treatment on oysters spiked with norovirus will reduce infection rates in people consuming raw infected oysters. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
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| Condition ICMJE | Healthy | ||||||||
| Intervention ICMJE | Procedure: High Hydrostatic Pressure Processing
High Hydrostatic Pressure Processing is a technology, used in the food service industry, where foods are subjected to high pressure. These high pressures kill many pathogens without affecting the quality of the food.
Other Name: HPP |
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| Study Arm (s) | Experimental: Shellfish with Norovirus
We dosed shellfish with Norovirus and challenged human volunteers with Shellfish that had norovirus
Intervention: Procedure: High Hydrostatic Pressure Processing |
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| Publications * | Leon JS, Kingsley DH, Montes JS, Richards GP, Lyon GM, Abdulhafid GM, Seitz SR, Fernandez ML, Teunis PF, Flick GJ, Moe CL. Randomized, double-blinded clinical trial for human norovirus inactivation in oysters by high hydrostatic pressure processing. Appl Environ Microbiol. 2011 Aug;77(15):5476-82. Epub 2011 Jun 24. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 51 | ||||||||
| Completion Date | March 2010 | ||||||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00674336 | ||||||||
| Other Study ID Numbers ICMJE | RSPHGH-CLM-2007-NoVSHELLFISH | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Christine Moe, PhD, Emory University | ||||||||
| Study Sponsor ICMJE | Emory University | ||||||||
| Collaborators ICMJE | Virginia Polytechnic Institute and State University | ||||||||
| Investigators ICMJE |
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| Information Provided By | Emory University | ||||||||
| Verification Date | March 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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