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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date October 2023
Source Groupe Hospitalier de la Rochelle Ré Aunis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
non-cholera Vibrio infection
Epidemiology of patients diagnosed with non-cholera Vibrio infection

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier de la Rochelle Ré Aunis

Country where clinical trial is conducted

France, 

References & Publications (5)

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

Outcome

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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