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

Necrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis (DHBN-FN) Mono- or Multi-microbial Streptococcus Beta-haemolytic: Study of Carriage in Patients and Their Entourage

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.

Study Overview

• Status: Unknown
• Conditions: Streptococcus Infection
• Intervention / Treatment: Other: DHBN-FN arm; Other: Control arm (Erysipelas)

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivier CHOSIDOW, Professor; Phone Number: +33(1)49812500; Email: olivier.chosidow@aphp.fr
• Study Contact Backup: Name: Camille HUA, Doctor; Phone Number: 01 49 87 81 72; Email: camille.hua@aphp.fr

Study Locations

• France
  • Créteil, France, 94000
    • Henri Mondor Hospital-AP-HP
    • Contact: Olivier CHOSIDOW, pROFESSOR
    • Contact: Camille HUA, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0
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	1 month after hospitalization discharge
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	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of SBH carriage at the time of diagnosis		Day 0, Day 10
Sites of SBH carriage at the time of diagnosis		Day 0, Day 10
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.	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.	Up to 10 Days
Main factors of streptococcal virulence	Analyze the main factors of streptococcal virulence by Streptococcal genome sequencing	Day 0, Day 10

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Olivier CHOSODOW, Professor, Henri Mondor University Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): October 1, 2020
• Study Completion (ANTICIPATED): November 1, 2020

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (ACTUAL): June 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Musculoskeletal Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Fasciitis; Streptococcal Infections; Fasciitis, Necrotizing
• Other Study ID Numbers: APHP180348

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No