Vibrio InfectionsINFECTIVENCT04451707
Epidemiology Non-cholera Vibrio Infections
An observational study of Vibrio Infections, run by Groupe Hospitalier de la Rochelle Ré Aunis at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vibrio Infections
- What is being tested?
- non-cholera Vibrio infection
- How many people
- 67 participants
- Where
- 7 sitesFrance
- Study dates
- 12 Mar 2020to 17 Jun 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with non-cholera Vibrio infection in Western France from 2000 to 2019
Who may be able to join
- non-cholera Vibrio infection
Who cannot join
- vibriosis to Vibrio cholerae O1 and O139
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU Angers
Angers
CHU Bordeaux
Bordeaux
Centre Hospitalier Départemental de la Vendée
La Roche-sur-Yon
CHU Nantes
Nantes
CHU Poitiers
Poitiers
CHU Rennes
Rennes
CHU Tours
Tours
About this study
Official title: 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.
Read the 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.
- Conditions
- Vibrio Infections
- Being tested
- non-cholera Vibrio infection
- Medical subject headings
- Vibrio Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-cholera Vibrio infectionOther
Epidemiology of patients diagnosed with non-cholera Vibrio infection
| Study group | Role | What they receive |
|---|---|---|
| non-cholera Vibrio infection | Patients diagnosed with non-cholera Vibrio infection in Western France from 2000 to 2019 Receives: Other: non-cholera Vibrio infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 20 years, from 2000-2019
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: at inclusion
Number of Participants by Month of the Years
Measured: at inclusion
Number of Participants Treated by Antibiotics
Measured: through study completion, an average of 1 month
Number of Participants Per Outcome
outcome :cure, cure with amputation, and deceased due to the infection
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start12 Mar 2020
- Primary completion17 Jun 2020
- Study completion17 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vibrio InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Hoefler, MD, Study director, Groupe Hospitalier de la Rochelle Ré Aunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451707
- Sponsor's protocol ID
- 2019/P02/358
- Acronym
- INFECTIVE
- Status last verified
- Oct 2023
- First submitted
- 24 Jun 2020
- Last updated
- 31 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 20546636Morris 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.
PubMed 12856219Givens 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.
PubMed 24571291Jones 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.
PubMed 19255188Hoefler 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.
PubMed 36418019
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Retrospective Study on the Clinical and Epidemiological Characteristics and Therapeutic Management of Non-cholera Vibrio Infections
- ClinicalTrials.gov ID
- NCT04451707
- Acronym / sponsor ID
- INFECTIVE / 2019/P02/358
- Conditions
- Vibrio Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré AunisUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 17 Jun 2020 (actual)
- Study completion
- 17 Jun 2020 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Posted 15 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-cholera Vibrio infection | – | Other: non-cholera Vibrio infectionPatients diagnosed with non-cholera Vibrio infection in Western France from 2000 to 2019 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with non-cholera Vibrio infection in Western France from 2000 to 2019
Key inclusion criteria (1 listed)
- non-cholera Vibrio infection
Key exclusion criteria (1 listed)
- vibriosis to Vibrio cholerae O1 and O139
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-cholera Vibrio infectionEpidemiology of patients diagnosed with non-cholera Vibrio infection | Other | non-cholera Vibrio infection |
Primary outcome
Number of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio Infection
Time frame: Up to 20 years, from 2000-2019
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.
6 secondary outcomes
Number of Patients Per Clinical History
Time frame: at inclusion
Number of Participants Associated With Environmental Factors
Time frame: at inclusion
Number of Participants Per Identified Species
Time frame: at inclusion
Number of Participants by Month of the Years
Time frame: at inclusion
Number of Participants Treated by Antibiotics
Time frame: through study completion, an average of 1 month
Number of Participants Per Outcome
Time frame: through study completion, an average of 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20546636Weis 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.
- Background: PubMed 12856219Morris 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.
- Background: PubMed 24571291Givens 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.
- Background: PubMed 19255188Jones 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.
- Results publication: PubMed 36418019Hoefler 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Hoefler, MD study director
Groupe Hospitalier de la Rochelle Ré Aunis
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vibrio Infections, run by Groupe Hospitalier de la Rochelle Ré Aunis at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio Infection (time frame: Up to 20 years, from 2000-2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04451707, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.