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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.
Vibrios are gram-negative, ubiquitous bacteria of the marine flora and are found particularly in warm waters. For example, the incidence is high in Florida and Vibrio infections are now reportable in the United States. Different species of Vibrio are described. A distinction is made between choleric vibrios belonging to serogroups O1 and O139, responsible for cholera epidemics, and non-choleric vibrios. Our study will focus on non-cholera vibrios. Vibrio infections can occur by eating contaminated raw seafood or by exposure of a wound to the marine environment. They occur mainly during the hot summer months. This can be explained on the one hand by higher water temperature and on the other hand by increased beach use. With global warming, it is possible that Vibrio infections may increase in number and location.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non-cholera Vibrio infection | Patients diagnosed with non-cholera Vibrio infection in Western France from 2000 to 2019 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-cholera Vibrio infection | Other | Epidemiology of patients diagnosed with non-cholera Vibrio infection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Participants Associated With Environmental Factors |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with non-cholera Vibrio infection in Western France from 2000 to 2019
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| Name | Affiliation | Role |
|---|---|---|
| Florence Hoefler, MD | Groupe Hospitalier de la Rochelle Ré Aunis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | France | ||||
| CHU Bordeaux |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20546636 | Background | 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. | |
| 12856219 | Background | 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. |
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Data will be made available with publication. Keyword are infection, non-cholera Vibrio, epidemiology The only available version will be the locked database. The database will be made available by the study director upon request up to 15 years after publication.
Medical Subject Headings (MESH) terms will be used to describe clinical data. Methodology for will be provided in the publication. International standard unit will be used.
From publication and up to 15 years after publication
Contact the corresponding author of the publication
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-cholerae or Non-O1/O139 Vibrio Infection | Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-cholera Vibrio Infection | Patients diagnosed with non-cholera Vibrio infection in Western France from 2000 to 2019 non-cholera Vibrio infection: Epidemiology of patients diagnosed with non-cholera Vibrio infection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Up to 20 years, from 2000-2019 |
|
|
One month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-cholerae or Non-O1/O139 Vibrio Infection | Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amputation | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Florence Hoefler | Groupe Hospitalier La Rochelle Ré Aunis | +330546455050 | florence.hoefler@ch-troyes.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2020 | Feb 19, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014735 | Vibrio Infections |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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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 |
| 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 |
| Number of Participants by Month of the Years | at inclusion |
| Number of Participants Treated by Antibiotics | through study completion, an average of 1 month |
| Number of Participants Per Outcome | outcome :cure, cure with amputation, and deceased due to the infection | through study completion, an average of 1 month |
| 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 | France |
| 24571291 | Background | 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. |
| 19255188 | Background | 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. |
| 36418019 | Result | 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, Bay of Biscay, France, 2001-2019. Emerg Infect Dis. 2022 Dec;28(12):2367-73. doi: 10.3201/eid2812.220748. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | at inclusion |
|
|
|
| Secondary | Number of Participants by Month of the Years | Posted | Count of Participants | Participants | at inclusion |
|
|
|
| Secondary | Number of Participants Treated by Antibiotics | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | through study completion, an average of 1 month |
|
|
|
| 8 |
| 67 |
| 35 |
| 67 |
| 41 |
| 67 |
| Surgery | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Near Drowning | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal and gastrointestinal infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment | Severe infection in a patient with cancer |
|
| Septic shock | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Necrotizing fasciitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment | patient with blood disease |
|
| Abdominal crampy pain | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Diarrhea | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Vomiting | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Nausea | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Headache | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Dyspnea | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
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|
| kidney failure |
|
| Immune disease |
|
| Haemopathy |
|
| Liver disease |
|
| Alcohol use disorder |
|
| Pre-existing wound |
|
| Digestive surgery |
|
| Title |
|---|
| Measurements |
|---|
|
| Walk on the beach |
|
| Seafood consumption |
|
| Handling of seafood products |
|
| Returning from a trip abroad |
|
| Unknown |
|
| Title |
|---|
| Measurements |
|---|
|
| Vibrio vulnificus |
|
| Vibrio spp |
|