Trial Outcomes & Findings for Epidemiology Non-cholera Vibrio Infections (NCT NCT04451707)
NCT ID: NCT04451707
Last Updated: 2023-10-31
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
67 participants
Primary outcome timeframe
Up to 20 years, from 2000-2019
Results posted on
2023-10-31
Participant Flow
Participant milestones
| Measure |
Non-cholerae or Non-O1/O139 Vibrio Infection
Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019
|
|---|---|
|
Overall Study
STARTED
|
67
|
|
Overall Study
COMPLETED
|
67
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Epidemiology Non-cholera Vibrio Infections
Baseline characteristics by cohort
| Measure |
Non-cholera Vibrio Infection
n=67 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=93 Participants
|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 24.2 • n=93 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
67 Participants
n=93 Participants
|
|
Region of Enrollment
France
|
67 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up 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.
Outcome measures
| Measure |
Non-cholerae or Non-O1/O139 Vibrio Infection
n=67 Participants
Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019
|
|---|---|
|
Number of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio Infection
Center 1
|
20 Participants
|
|
Number of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio Infection
Center 2
|
7 Participants
|
|
Number of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio Infection
Center 4
|
18 Participants
|
|
Number of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio Infection
Center 5
|
10 Participants
|
|
Number of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio Infection
Center 6
|
1 Participants
|
|
Number of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio Infection
Center 3
|
2 Participants
|
|
Number of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio Infection
Center 7
|
1 Participants
|
|
Number of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio Infection
Center 8
|
8 Participants
|
SECONDARY outcome
Timeframe: at inclusionClinical history: diabetes, heart failure, hepatopathy, neoplasia, alcohol use disorder, Immunosuppressive drug, Pre-existing wound, Digestive surgery, Hemopathy, Kidney Disease
Outcome measures
| Measure |
Non-cholerae or Non-O1/O139 Vibrio Infection
n=67 Participants
Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019
|
|---|---|
|
Number of Patients Per Clinical History
Heart failure
|
24 Participants
|
|
Number of Patients Per Clinical History
Neoplasia
|
11 Participants
|
|
Number of Patients Per Clinical History
Diabetes
|
8 Participants
|
|
Number of Patients Per Clinical History
kidney failure
|
7 Participants
|
|
Number of Patients Per Clinical History
Immune disease
|
7 Participants
|
|
Number of Patients Per Clinical History
Haemopathy
|
5 Participants
|
|
Number of Patients Per Clinical History
Liver disease
|
5 Participants
|
|
Number of Patients Per Clinical History
Alcohol use disorder
|
7 Participants
|
|
Number of Patients Per Clinical History
Pre-existing wound
|
6 Participants
|
|
Number of Patients Per Clinical History
Digestive surgery
|
6 Participants
|
SECONDARY outcome
Timeframe: at 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
Outcome measures
| Measure |
Non-cholerae or Non-O1/O139 Vibrio Infection
n=67 Participants
Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019
|
|---|---|
|
Number of Participants Associated With Environmental Factors
Bathing in the sea
|
12 Participants
|
|
Number of Participants Associated With Environmental Factors
Injury in the aquatic environment
|
5 Participants
|
|
Number of Participants Associated With Environmental Factors
Aquatic activities
|
3 Participants
|
|
Number of Participants Associated With Environmental Factors
Walk on the beach
|
2 Participants
|
|
Number of Participants Associated With Environmental Factors
Seafood consumption
|
7 Participants
|
|
Number of Participants Associated With Environmental Factors
Handling of seafood products
|
7 Participants
|
|
Number of Participants Associated With Environmental Factors
Returning from a trip abroad
|
2 Participants
|
|
Number of Participants Associated With Environmental Factors
Unknown
|
29 Participants
|
SECONDARY outcome
Timeframe: at inclusionSpecies: Vibrio alginolyticus, Vibrio cholerae Non-O1/Non-O139 Non toxinogenic, Vibrio parahaemolyticus, Vibrio vulnificus, Vibrio sp or other
Outcome measures
| Measure |
Non-cholerae or Non-O1/O139 Vibrio Infection
n=67 Participants
Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019
|
|---|---|
|
Number of Participants Per Identified Species
Vibrio alginolyticus
|
23 Participants
|
|
Number of Participants Per Identified Species
Vibrio parahaemolyticus
|
20 Participants
|
|
Number of Participants Per Identified Species
Non-O1/O139 Vibrio cholerae
|
10 Participants
|
|
Number of Participants Per Identified Species
Vibrio vulnificus
|
7 Participants
|
|
Number of Participants Per Identified Species
Vibrio spp
|
7 Participants
|
SECONDARY outcome
Timeframe: at inclusionOutcome measures
| Measure |
Non-cholerae or Non-O1/O139 Vibrio Infection
n=67 Participants
Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019
|
|---|---|
|
Number of Participants by Month of the Years
May
|
1 Participants
|
|
Number of Participants by Month of the Years
June
|
6 Participants
|
|
Number of Participants by Month of the Years
July
|
14 Participants
|
|
Number of Participants by Month of the Years
August
|
19 Participants
|
|
Number of Participants by Month of the Years
September
|
11 Participants
|
|
Number of Participants by Month of the Years
January
|
0 Participants
|
|
Number of Participants by Month of the Years
February
|
0 Participants
|
|
Number of Participants by Month of the Years
March
|
1 Participants
|
|
Number of Participants by Month of the Years
April
|
0 Participants
|
|
Number of Participants by Month of the Years
October
|
6 Participants
|
|
Number of Participants by Month of the Years
Novermber
|
2 Participants
|
|
Number of Participants by Month of the Years
December
|
1 Participants
|
|
Number of Participants by Month of the Years
Unknown
|
6 Participants
|
SECONDARY outcome
Timeframe: through study completion, an average of 1 monthOutcome measures
| Measure |
Non-cholerae or Non-O1/O139 Vibrio Infection
n=67 Participants
Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019
|
|---|---|
|
Number of Participants Treated by Antibiotics
Treated by antibiotics
|
53 Participants
|
|
Number of Participants Treated by Antibiotics
Did not received antibiotics
|
5 Participants
|
|
Number of Participants Treated by Antibiotics
unknown
|
9 Participants
|
SECONDARY outcome
Timeframe: through study completion, an average of 1 monthoutcome :cure, cure with amputation, and deceased due to the infection
Outcome measures
| Measure |
Non-cholerae or Non-O1/O139 Vibrio Infection
n=67 Participants
Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019
|
|---|---|
|
Number of Participants Per Outcome
Cured
|
53 Participants
|
|
Number of Participants Per Outcome
Amputation
|
6 Participants
|
|
Number of Participants Per Outcome
Infection related death
|
8 Participants
|
Adverse Events
Non-cholerae or Non-O1/O139 Vibrio Infection
Serious events: 35 serious events
Other events: 41 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Non-cholerae or Non-O1/O139 Vibrio Infection
n=67 participants at risk
Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019
|
|---|---|
|
Infections and infestations
Amputation
|
9.0%
6/67 • One month
|
|
Infections and infestations
Surgery
|
31.3%
21/67 • One month
|
|
Infections and infestations
Near Drowning
|
4.5%
3/67 • One month
|
|
Infections and infestations
Abdominal and gastrointestinal infection
|
1.5%
1/67 • One month
|
|
Infections and infestations
Septic shock
|
4.5%
3/67 • One month
|
|
Infections and infestations
Necrotizing fasciitis
|
1.5%
1/67 • One month
|
Other adverse events
| Measure |
Non-cholerae or Non-O1/O139 Vibrio Infection
n=67 participants at risk
Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019
|
|---|---|
|
Infections and infestations
Fever
|
43.3%
29/67 • One month
|
|
Infections and infestations
Abdominal crampy pain
|
29.9%
20/67 • One month
|
|
Infections and infestations
Diarrhea
|
28.4%
19/67 • One month
|
|
Infections and infestations
Vomiting
|
19.4%
13/67 • One month
|
|
Infections and infestations
Nausea
|
16.4%
11/67 • One month
|
|
Infections and infestations
Headache
|
3.0%
2/67 • One month
|
|
Infections and infestations
Dyspnea
|
13.4%
9/67 • One month
|
Additional Information
Dr Florence Hoefler
Groupe Hospitalier La Rochelle Ré Aunis
Phone: +330546455050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place