NCT04451707

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
9 months until next milestone

Results Posted

Study results publicly available

March 15, 2021

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

June 24, 2020

Results QC Date

February 19, 2021

Last Update Submit

October 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Number of Patients Per Clinical History

    at inclusion

  • Number of Participants Associated With Environmental Factors

    at inclusion

  • Number of Participants Per Identified Species

    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

  • +1 more secondary outcomes

Study Arms (1)

non-cholera Vibrio infection

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

Other: non-cholera Vibrio infection

Interventions

Epidemiology of patients diagnosed with non-cholera Vibrio infection

non-cholera Vibrio infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • non-cholera Vibrio infection

You may not qualify if:

  • vibriosis to Vibrio cholerae O1 and O139

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CHU Angers

Angers, France

Location

CHU Bordeaux

Bordeaux, France

Location

Centre Hospitalier Départemental de la Vendée

La Roche-sur-Yon, France

Location

CHU Nantes

Nantes, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Rennes

Rennes, France

Location

CHU Tours

Tours, France

Location

Related Publications (5)

  • 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.

    PMID: 20546636BACKGROUND
  • 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.

    PMID: 12856219BACKGROUND
  • 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.

    PMID: 24571291BACKGROUND
  • 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.

    PMID: 19255188BACKGROUND
  • 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.

MeSH Terms

Conditions

Vibrio Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Results Point of Contact

Title
Dr Florence Hoefler
Organization
Groupe Hospitalier La Rochelle Ré Aunis

Study Officials

  • Florence Hoefler, MD

    Groupe Hospitalier de la Rochelle Ré Aunis

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2020

First Posted

June 30, 2020

Study Start

March 12, 2020

Primary Completion

June 17, 2020

Study Completion

June 17, 2020

Last Updated

October 31, 2023

Results First Posted

March 15, 2021

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
CSR
Time Frame
From publication and up to 15 years after publication
Access Criteria
Contact the corresponding author of the publication

Locations