Necrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis Mono- or Multi-microbial Streptococcus Beta-haemolytic

Not Applicable

• Conditions: Streptococcus Infection
• Interventions: Other: DHBN-FN arm; Other: Control arm (Erysipelas)

• Registration Number: NCT03976024
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 available

Study Timeline

• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-05
• Status Verified: 2019-12
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-20
• Study Start: 2020-09-01
• Primary Completion: 2020-10-01
• Study Completion: 2020-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DHBN-FN arm	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
Control arm (Erysipelas)	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).

Primary Outcome Measures

Name	Time	Method
Rate of beta-hemolytic streptococcus in patients with DHBN-FN	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

Name	Time	Method
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	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	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	Day 0, Day 10	Analyze the main factors of streptococcal virulence by Streptococcal genome sequencing

Trial Locations

Locations (1)

Henri Mondor Hospital-AP-HP; 🇫🇷 Créteil, France