Vibrio Infections Clinical Trial
— INFECTIVEOfficial title:
Multicentre Retrospective Study on the Clinical and Epidemiological Characteristics and Therapeutic Management of Non-cholera Vibrio Infections
NCT number | NCT04451707 |
Other study ID # | 2019/P02/358 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 12, 2020 |
Est. completion date | June 17, 2020 |
Verified date | October 2023 |
Source | Groupe Hospitalier de la Rochelle Ré Aunis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to identify the epidemiological and clinical characteristics of patients diagnosed with non-cholera Vibrio infection in Western France from 2000 to 2019.
Status | Completed |
Enrollment | 67 |
Est. completion date | June 17, 2020 |
Est. primary completion date | June 17, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - non-cholera Vibrio infection Exclusion Criteria: - vibriosis to Vibrio cholerae O1 and O139 |
Country | Name | City | State |
---|---|---|---|
France | CHU Angers | Angers | |
France | CHU Bordeaux | Bordeaux | |
France | Centre Hospitalier Départemental de la Vendée | La Roche-sur-Yon | |
France | CHU Nantes | Nantes | |
France | CHU Poitiers | Poitiers | |
France | CHU Rennes | Rennes | |
France | CHU Tours | Tours |
Lead Sponsor | Collaborator |
---|---|
Groupe Hospitalier de la Rochelle Ré Aunis |
France,
Givens CE, Bowers JC, DePaola A, Hollibaugh JT, Jones JL. Occurrence and distribution of Vibrio vulnificus and Vibrio parahaemolyticus--potential roles for fish, oyster, sediment and water. Lett Appl Microbiol. 2014 Jun;58(6):503-10. doi: 10.1111/lam.12226. Epub 2014 Feb 27. — View Citation
Hoefler F, Pouget-Abadie X, Roncato-Saberan M, Lemarie R, Takoudju EM, Raffi F, Corvec S, Le Bras M, Cazanave C, Lehours P, Guimard T, Allix-Beguec C. Clinical and Epidemiologic Characteristics and Therapeutic Management of Patients with Vibrio Infections — View Citation
Jones MK, Oliver JD. Vibrio vulnificus: disease and pathogenesis. Infect Immun. 2009 May;77(5):1723-33. doi: 10.1128/IAI.01046-08. Epub 2009 Mar 2. No abstract available. — View Citation
Morris JG Jr. Cholera and other types of vibriosis: a story of human pandemics and oysters on the half shell. Clin Infect Dis. 2003 Jul 15;37(2):272-80. doi: 10.1086/375600. Epub 2003 Jul 3. — View Citation
Weis KE, Hammond RM, Hutchinson R, Blackmore CG. Vibrio illness in Florida, 1998-2007. Epidemiol Infect. 2011 Apr;139(4):591-8. doi: 10.1017/S0950268810001354. Epub 2010 Jun 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio Infection | A non-cholerae or non-O1/O139 Vibrio infection was defined by a biological sample (blood, superficial sample, deep sample, and ear sample) positive to a Vibrio species other than Vibrio cholerae O1-O139. | Up to 20 years, from 2000-2019 | |
Secondary | Number of Patients Per Clinical History | Clinical history: diabetes, heart failure, hepatopathy, neoplasia, alcohol use disorder, Immunosuppressive drug, Pre-existing wound, Digestive surgery, Hemopathy, Kidney Disease | at inclusion | |
Secondary | Number of Participants Associated With Environmental Factors | environmental factors : seafood consumption, bathing/water activity, Injury in the aquatic environment, Walk to the beach, Handling of seafood products, returning from a trip abroad | at inclusion | |
Secondary | Number of Participants Per Identified Species | Species: Vibrio alginolyticus, Vibrio cholerae Non-O1/Non-O139 Non toxinogenic, Vibrio parahaemolyticus, Vibrio vulnificus, Vibrio sp or other | at inclusion | |
Secondary | Number of Participants by Month of the Years | at inclusion | ||
Secondary | Number of Participants Treated by Antibiotics | through study completion, an average of 1 month | ||
Secondary | Number of Participants Per Outcome | outcome :cure, cure with amputation, and deceased due to the infection | through study completion, an average of 1 month |
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