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Epidemiology Non-cholera Vibrio Infections

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04451707
Acronym
INFECTIVE
Enrollment
67
Registered
2020-06-30
Start date
2020-03-12
Completion date
2020-06-17
Last updated
2023-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vibrio Infections

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.

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.

Interventions

OTHERnon-cholera Vibrio infection

Epidemiology of patients diagnosed with non-cholera Vibrio infection

Sponsors

Groupe Hospitalier de la Rochelle Ré Aunis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* non-cholera Vibrio infection

Exclusion criteria

* vibriosis to Vibrio cholerae O1 and O139

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio InfectionUp to 20 years, from 2000-2019A 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.

Secondary

MeasureTime frameDescription
Number of Participants Associated With Environmental Factorsat inclusionenvironmental factors : seafood consumption, bathing/water activity, Injury in the aquatic environment, Walk to the beach, Handling of seafood products, returning from a trip abroad
Number of Participants Per Identified Speciesat inclusionSpecies: Vibrio alginolyticus, Vibrio cholerae Non-O1/Non-O139 Non toxinogenic, Vibrio parahaemolyticus, Vibrio vulnificus, Vibrio sp or other
Number of Patients Per Clinical Historyat inclusionClinical history: diabetes, heart failure, hepatopathy, neoplasia, alcohol use disorder, Immunosuppressive drug, Pre-existing wound, Digestive surgery, Hemopathy, Kidney Disease
Number of Participants Treated by Antibioticsthrough study completion, an average of 1 month
Number of Participants Per Outcomethrough study completion, an average of 1 monthoutcome :cure, cure with amputation, and deceased due to the infection
Number of Participants by Month of the Yearsat inclusion

Countries

France

Participant flow

Participants by arm

ArmCount
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
67
Total67

Baseline characteristics

CharacteristicNon-cholera Vibrio Infection
Age, Categorical
<=18 years
11 Participants
Age, Categorical
>=65 years
28 Participants
Age, Categorical
Between 18 and 65 years
28 Participants
Age, Continuous54.4 years
STANDARD_DEVIATION 24.2
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
67 Participants
Region of Enrollment
France
67 participants
Sex: Female, Male
Female
13 Participants
Sex: Female, Male
Male
54 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
8 / 67
other
Total, other adverse events
41 / 67
serious
Total, serious adverse events
35 / 67

Outcome results

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.

Time frame: Up to 20 years, from 2000-2019

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio InfectionCenter 120 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio InfectionCenter 27 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio InfectionCenter 32 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio InfectionCenter 418 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio InfectionCenter 510 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio InfectionCenter 61 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio InfectionCenter 71 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio InfectionCenter 88 Participants
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

Time frame: at inclusion

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants Associated With Environmental FactorsBathing in the sea12 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants Associated With Environmental FactorsInjury in the aquatic environment5 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants Associated With Environmental FactorsAquatic activities3 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants Associated With Environmental FactorsWalk on the beach2 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants Associated With Environmental FactorsSeafood consumption7 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants Associated With Environmental FactorsHandling of seafood products7 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants Associated With Environmental FactorsReturning from a trip abroad2 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants Associated With Environmental FactorsUnknown29 Participants
Secondary

Number of Participants by Month of the Years

Time frame: at inclusion

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants by Month of the YearsJanuary0 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants by Month of the YearsFebruary0 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants by Month of the YearsMarch1 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants by Month of the YearsApril0 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants by Month of the YearsMay1 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants by Month of the YearsJune6 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants by Month of the YearsJuly14 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants by Month of the YearsAugust19 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants by Month of the YearsSeptember11 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants by Month of the YearsOctober6 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants by Month of the YearsNovermber2 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants by Month of the YearsDecember1 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants by Month of the YearsUnknown6 Participants
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

Time frame: at inclusion

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants Per Identified SpeciesVibrio alginolyticus23 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants Per Identified SpeciesVibrio parahaemolyticus20 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants Per Identified SpeciesNon-O1/O139 Vibrio cholerae10 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants Per Identified SpeciesVibrio vulnificus7 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants Per Identified SpeciesVibrio spp7 Participants
Secondary

Number of Participants Per Outcome

outcome :cure, cure with amputation, and deceased due to the infection

Time frame: through study completion, an average of 1 month

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants Per OutcomeCured53 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants Per OutcomeAmputation6 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants Per OutcomeInfection related death8 Participants
Secondary

Number of Participants Treated by Antibiotics

Time frame: through study completion, an average of 1 month

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants Treated by AntibioticsTreated by antibiotics53 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants Treated by AntibioticsDid not received antibiotics5 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Participants Treated by Antibioticsunknown9 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

Time frame: at inclusion

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Patients Per Clinical HistoryHeart failure24 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Patients Per Clinical HistoryNeoplasia11 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Patients Per Clinical HistoryDiabetes8 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Patients Per Clinical Historykidney failure7 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Patients Per Clinical HistoryImmune disease7 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Patients Per Clinical HistoryHaemopathy5 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Patients Per Clinical HistoryLiver disease5 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Patients Per Clinical HistoryAlcohol use disorder7 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Patients Per Clinical HistoryPre-existing wound6 Participants
Non-cholerae or Non-O1/O139 Vibrio InfectionNumber of Patients Per Clinical HistoryDigestive surgery6 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026