Back to resultsNecrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis Mono- or Multi-microbial Streptococcus Beta-haemolytic (STREPTO-FAST)
Primary Purpose
Streptococcus Infection
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
DHBN-FN arm
Control arm (Erysipelas)
Sponsored by
About this trial
This is an interventional prevention trial for Streptococcus Infection
Eligibility Criteria
Inclusion Criteria:
- Patient:
- Major patient hospitalized for a DHBN-FN or erysipelas (clinical diagnosis determined at the entrance).
- Signed informed consent.
Case contact
- person of major age living under the same roof as a patient who has had a DHBN-FN.
- Signed informed consent
Exclusion Criteria:
- Patient:
- Minor patient
- Immunosuppressed patient: active hematology, poorly controlled HIV, neutropenia (PNN <1000 / mm3).
- Patient under guardianship or curatorship
- Patient deprived of liberty by judicial or administrative decision
- Patient not affiliated to a social security scheme and not a beneficiary of such a scheme
Case contact
- Minor person
- Person under tutorship or curatorship
- Person deprived of liberty by judicial or administrative decision
- Person not affiliated with a social security
Sites / Locations
- Henri Mondor Hospital-AP-HP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DHBN-FN arm
Control arm (Erysipelas)
Arm Description
Recruitment is planned in traditional hospitalization for DHBN-FN patients. Evaluation of streptococcal carriage by swab, pharyngeal, anal and perineal in patients hospitalized for a DHBN-FN at the end of hospitalization and 1 month after discharge from hospital during the reassessment consultation. Swabs made by the dermatologist. The carriage of streptococcus in patients living under the same roof as patients with DHBN-FN will be evaluated by pharyngeal swab, anal and perineal. If the family accepts, the carriage of streptococcus in persons living under the same roof as patients with DHBN-FN will be evaluated by pharyngeal, anal and perineal swab in consultation. These swabs will be made within 10 days of diagnosis of DHBN-FN of the index
Recruitment is planned in traditional hospitalization for patients with erysipelas. The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0 (admission).
Outcomes
Primary Outcome Measures
Rate of beta-hemolytic streptococcus in patients with DHBN-FN
Evaluation of streptococcal carriage by swab, pharyngeal, anal and perineal in patients hospitalized for a DHBN-FN . Swabs made by the dermatologist. The detection of beta-hemolytic streptococcus will be made by culture
Rate of beta-hemolytic streptococcus in patients with DHBN-FN
Evaluation of streptococcal carriage by swab, pharyngeal, anal and perineal in patients hospitalized for a DHBN-FN . Swabs made by the dermatologist. The detection of beta-hemolytic streptococcus will be made by culture
Rate of beta-hemolytic streptococcus in patients with DHBN-FN
Evaluation of streptococcal carriage by swab, pharyngeal, anal and perineal in patients hospitalized for a DHBN-FN . Swabs made by the dermatologist. The detection of beta-hemolytic streptococcus will be made by culture
Secondary Outcome Measures
Prevalence of SBH carriage at the time of diagnosis
Sites of SBH carriage at the time of diagnosis
Rate of beta-hemolytic streptococcus in patients with erysipelas
The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0.
Rate of beta-hemolytic streptococcus in patients living under the same roof as patients with DHBN-FN
The carriage of streptococcus in persons living under the same roof as patients with DHBN-FN will be evaluated by pharyngeal, anal and perineal swab in consultation. These swabs will be made within 10 days of diagnosis of DHBN-FN of the index.
Main factors of streptococcal virulence
Analyze the main factors of streptococcal virulence by Streptococcal genome sequencing
Full Information
NCT ID
NCT03976024
First Posted
March 15, 2019
Last Updated
May 19, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03976024
Brief Title
Necrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis Mono- or Multi-microbial Streptococcus Beta-haemolytic
Acronym
STREPTO-FAST
Official Title
Necrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis (DHBN-FN) Mono- or Multi-microbial Streptococcus Beta-haemolytic: Study of Carriage in Patients and Their Entourage
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
November 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to evaluate streptococcal carriage by swab, pharyngeal, anal and perineal in patients with DHBN-FN, in the entourage living under the same roof as well as patients with erysipelas
The main hypothesis is the major role of chronic porting of patients and entourage in DHBN-FN to SBH.
Indeed, the chronic pharyngeal / anal / perineal carriage could be a gateway following a transient bacteremia for a DHBN-FN.
The transmission of germs from the surrounding to the patient plays a major role:
At the gateway level in the case of exogenous DHBN-FN At the origin of chronic carriage in the case of endogenous DHBN-FN Transmission of germs from the patient to the surrounding area also plays an important role in increasing the risk of invasive SBH infections in the surrounding area.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Streptococcus Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DHBN-FN arm
Arm Type
Experimental
Arm Description
Recruitment is planned in traditional hospitalization for DHBN-FN patients. Evaluation of streptococcal carriage by swab, pharyngeal, anal and perineal in patients hospitalized for a DHBN-FN at the end of hospitalization and 1 month after discharge from hospital during the reassessment consultation. Swabs made by the dermatologist.
The carriage of streptococcus in patients living under the same roof as patients with DHBN-FN will be evaluated by pharyngeal swab, anal and perineal. If the family accepts, the carriage of streptococcus in persons living under the same roof as patients with DHBN-FN will be evaluated by pharyngeal, anal and perineal swab in consultation. These swabs will be made within 10 days of diagnosis of DHBN-FN of the index
Arm Title
Control arm (Erysipelas)
Arm Type
Active Comparator
Arm Description
Recruitment is planned in traditional hospitalization for patients with erysipelas.
The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0 (admission).
Intervention Type
Other
Intervention Name(s)
DHBN-FN arm
Intervention Description
DHBN-FN will be evaluated by pharyngeal swab, anal and perineal. If the family accepts, the carriage of streptococcus in persons living under the same roof as patients with DHBN-FN will be evaluated by pharyngeal, anal and perineal swab in consultation. These swabs will be made within 10 days of diagnosis of DHBN-FN of the index
Intervention Type
Other
Intervention Name(s)
Control arm (Erysipelas)
Intervention Description
The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0 (admission).
Primary Outcome Measure Information:
Title
Rate of beta-hemolytic streptococcus in patients with DHBN-FN
Description
Evaluation of streptococcal carriage by swab, pharyngeal, anal and perineal in patients hospitalized for a DHBN-FN . Swabs made by the dermatologist. The detection of beta-hemolytic streptococcus will be made by culture
Time Frame
Day 0
Title
Rate of beta-hemolytic streptococcus in patients with DHBN-FN
Description
Evaluation of streptococcal carriage by swab, pharyngeal, anal and perineal in patients hospitalized for a DHBN-FN . Swabs made by the dermatologist. The detection of beta-hemolytic streptococcus will be made by culture
Time Frame
1 month after hospitalization discharge
Title
Rate of beta-hemolytic streptococcus in patients with DHBN-FN
Description
Evaluation of streptococcal carriage by swab, pharyngeal, anal and perineal in patients hospitalized for a DHBN-FN . Swabs made by the dermatologist. The detection of beta-hemolytic streptococcus will be made by culture
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Prevalence of SBH carriage at the time of diagnosis
Time Frame
Day 0, Day 10
Title
Sites of SBH carriage at the time of diagnosis
Time Frame
Day 0, Day 10
Title
Rate of beta-hemolytic streptococcus in patients with erysipelas
Description
The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0.
Time Frame
Day 0
Title
Rate of beta-hemolytic streptococcus in patients living under the same roof as patients with DHBN-FN
Description
The carriage of streptococcus in persons living under the same roof as patients with DHBN-FN will be evaluated by pharyngeal, anal and perineal swab in consultation. These swabs will be made within 10 days of diagnosis of DHBN-FN of the index.
Time Frame
Up to 10 Days
Title
Main factors of streptococcal virulence
Description
Analyze the main factors of streptococcal virulence by Streptococcal genome sequencing
Time Frame
Day 0, Day 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient:
Major patient hospitalized for a DHBN-FN or erysipelas (clinical diagnosis determined at the entrance).
Signed informed consent.
Case contact
person of major age living under the same roof as a patient who has had a DHBN-FN.
Signed informed consent
Exclusion Criteria:
Patient:
Minor patient
Immunosuppressed patient: active hematology, poorly controlled HIV, neutropenia (PNN <1000 / mm3).
Patient under guardianship or curatorship
Patient deprived of liberty by judicial or administrative decision
Patient not affiliated to a social security scheme and not a beneficiary of such a scheme
Case contact
Minor person
Person under tutorship or curatorship
Person deprived of liberty by judicial or administrative decision
Person not affiliated with a social security
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier CHOSIDOW, Professor
Phone
+33(1)49812500
Email
olivier.chosidow@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Camille HUA, Doctor
Phone
01 49 87 81 72
Email
camille.hua@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier CHOSODOW, Professor
Organizational Affiliation
Henri Mondor University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital-AP-HP
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier CHOSIDOW, pROFESSOR
First Name & Middle Initial & Last Name & Degree
Camille HUA, Doctor
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Necrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis Mono- or Multi-microbial Streptococcus Beta-haemolytic
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