Epidemiology Non-cholera Vibrio Infections (INFECTIVE)

Multicentre Retrospective Study on the Clinical and Epidemiological Characteristics and Therapeutic Management of Non-cholera Vibrio Infections

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.

Study Overview

• Status: Completed
• Conditions: Vibrio Infections
• Intervention / Treatment: Other: non-cholera Vibrio infection

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• France
  • Angers, France
    • CHU Angers
  • Bordeaux, France
    • CHU Bordeaux
  • La Roche-sur-Yon, France
    • Centre Hospitalier Départemental de la Vendée
  • Nantes, France
    • CHU Nantes
  • Poitiers, France
    • CHU Poitiers
  • Rennes, France
    • CHU Rennes
  • Tours, France
    • Chu Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with non-cholera Vibrio infection in Western France from 2000 to 2019

Description

Inclusion Criteria:

• non-cholera Vibrio infection

Exclusion Criteria:

• vibriosis to Vibrio cholerae O1 and O139

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
non-cholera Vibrio infection; Patients diagnosed with non-cholera Vibrio infection in Western France from 2000 to 2019	Other: non-cholera Vibrio infection; Epidemiology of patients diagnosed with non-cholera Vibrio infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis
• Investigators: Study Director: Florence Hoefler, MD, Groupe Hospitalier de la Rochelle Ré Aunis

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2020
• Primary Completion (Actual): June 17, 2020
• Study Completion (Actual): June 17, 2020

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Vibrio Infections
• Other Study ID Numbers: 2019/P02/358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: From publication and up to 15 years after publication
• IPD Sharing Access Criteria: Contact the corresponding author of the publication
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No