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出境医 / 临床实验 / Necrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis Mono- or Multi-microbial Streptococcus Beta-haemolytic (STREPTO-FAST)

Necrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis Mono- or Multi-microbial Streptococcus Beta-haemolytic (STREPTO-FAST)

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.


Condition or disease Intervention/treatment Phase
Streptococcus Infection Other: DHBN-FN arm Other: Control arm (Erysipelas) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Necrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis (DHBN-FN) Mono- or Multi-microbial Streptococcus Beta-haemolytic: Study of Carriage in Patients and Their Entourage
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : November 1, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: DHBN-FN arm

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

 Other: DHBN-FN arm
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
Active Comparator: Control arm (Erysipelas)

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).

 Other: Control arm (Erysipelas)
The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0 (admission).
Outcome Measures
Primary Outcome Measures :
  1. Rate of beta-hemolytic streptococcus in patients with DHBN-FN [ Time Frame: Day 0 ]
    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

  2. Rate of beta-hemolytic streptococcus in patients with DHBN-FN [ Time Frame: 1 month after hospitalization discharge ]
    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

  3. Rate of beta-hemolytic streptococcus in patients with DHBN-FN [ Time Frame: Day 30 ]
    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 :
  1. Prevalence of SBH carriage at the time of diagnosis [ Time Frame: Day 0, Day 10 ]
  2. Sites of SBH carriage at the time of diagnosis [ Time Frame: Day 0, Day 10 ]
  3. Rate of beta-hemolytic streptococcus in patients with erysipelas [ Time Frame: Day 0 ]
    The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0.

  4. Rate of beta-hemolytic streptococcus in patients living under the same roof as patients with DHBN-FN [ Time Frame: Up to 10 Days ]
    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.

  5. Main factors of streptococcal virulence [ Time Frame: Day 0, Day 10 ]
    Analyze the main factors of streptococcal virulence by Streptococcal genome sequencing


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Contacts
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Contact: Olivier CHOSIDOW, Professor +33(1)49812500 olivier.chosidow@aphp.fr
Contact: Camille HUA, Doctor 01 49 87 81 72 camille.hua@aphp.fr

Locations
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France
Henri Mondor Hospital-AP-HP
Créteil, France, 94000
Contact: Olivier CHOSIDOW, pROFESSOR         
Contact: Camille HUA, Doctor         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Olivier CHOSODOW, Professor Henri Mondor Hospital
Tracking Information
First Submitted Date  ICMJE March 15, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date May 20, 2020
Estimated Study Start Date  ICMJE September 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • Rate of beta-hemolytic streptococcus in patients with DHBN-FN [ Time Frame: Day 0 ]
    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 [ Time Frame: 1 month after hospitalization discharge ]
    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 [ Time Frame: Day 30 ]
    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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • Prevalence of SBH carriage at the time of diagnosis [ Time Frame: Day 0, Day 10 ]
  • Sites of SBH carriage at the time of diagnosis [ Time Frame: Day 0, Day 10 ]
  • Rate of beta-hemolytic streptococcus in patients with erysipelas [ Time Frame: Day 0 ]
    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 [ Time Frame: Up to 10 Days ]
    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 [ Time Frame: Day 0, Day 10 ]
    Analyze the main factors of streptococcal virulence by Streptococcal genome sequencing
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Necrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis Mono- or Multi-microbial Streptococcus Beta-haemolytic
Official Title  ICMJE Necrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis (DHBN-FN) Mono- or Multi-microbial Streptococcus Beta-haemolytic: Study of Carriage in Patients and Their Entourage
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Streptococcus Infection
Intervention  ICMJE
  • Other: DHBN-FN arm
    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
  • Other: Control arm (Erysipelas)
    The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0 (admission).
Study Arms  ICMJE
  • Experimental: DHBN-FN arm

    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

    Intervention: Other: DHBN-FN arm
  • Active Comparator: Control arm (Erysipelas)

    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: Other: Control arm (Erysipelas)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Olivier CHOSIDOW, Professor +33(1)49812500 olivier.chosidow@aphp.fr
Contact: Camille HUA, Doctor 01 49 87 81 72 camille.hua@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03976024
Other Study ID Numbers  ICMJE APHP180348
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Olivier CHOSODOW, Professor Henri Mondor Hospital
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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