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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | April 10, 2006 | ||||||||||||
| Last Updated Date | May 8, 2008 | ||||||||||||
| Start Date ICMJE | February 2006 | ||||||||||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Infection with norovirus [ Time Frame: Throughout study ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00313404 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Infectivity of Norovirus in Groundwater-Human Challenge Study | ||||||||||||
| Official Title ICMJE | Assessment of Calicivirus Survival in Surface Water and Subsurface Water | ||||||||||||
| 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 see how long Norwalk virus can survive in water and still be able to cause sickness. When this is determined the researchers will be able to recommend risk levels for norovirus contaminated waters. Another purpose for this study is to see how a person's body's immune cells respond to Norwalk virus in the body. During this study volunteers will receive a dose of Norwalk virus in water that may make them sick. |
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| Detailed Description | |||||||||||||
| Study Phase | |||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Prevention, Randomized, Single Blind (Subject), Dose Comparison, Single Group Assignment, Efficacy Study | ||||||||||||
| Condition ICMJE | Healthy | ||||||||||||
| Intervention ICMJE | Biological: Safety tested norovirus inoculum | ||||||||||||
| Study Arms / Comparison Groups | |||||||||||||
| Publications * | |||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Suspended | ||||||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||||||
| Estimated Completion Date | December 2010 | ||||||||||||
| Primary Completion Date | May 2008 (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 ID ICMJE | NCT00313404 | ||||||||||||
| Responsible Party | Christine Moe, Emory University | ||||||||||||
| Study ID Numbers ICMJE | RSPHGH-CLM-2005-EPANoV, EPA-5 R01 AI056351-03 | ||||||||||||
| Study Sponsor ICMJE | Emory University | ||||||||||||
| Collaborators ICMJE | Johns Hopkins University | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Emory University | ||||||||||||
| Verification Date | May 2008 | ||||||||||||
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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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