Clinical trial NCT03976024: Necrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis Mono- or Multi-microbial Streptococcus Beta-haemolytic
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
Overall status: UNKNOWN
Phase: NA
Conditions: Streptococcus Infection
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Rate of beta-hemolytic streptococcus in patients with DHBN-FN
timeFrame: Day 0
measure: Rate of beta-hemolytic streptococcus in patients with DHBN-FN
timeFrame: 1 month after hospitalization discharge
measure: Rate of beta-hemolytic streptococcus in patients with DHBN-FN
timeFrame: Day 30
Secondary outcomes:
measure: Prevalence of SBH carriage at the time of diagnosis
timeFrame: Day 0, Day 10
measure: Sites of SBH carriage at the time of diagnosis
timeFrame: Day 0, Day 10
measure: Rate of beta-hemolytic streptococcus in patients with erysipelas
timeFrame: Day 0
measure: Rate of beta-hemolytic streptococcus in patients living under the same roof as patients with DHBN-FN
timeFrame: Up to 10 Days
measure: Main factors of streptococcal virulence
timeFrame: Day 0, Day 10
Other outcomes:
Locations:
city: Créteil
country: France
facility: Henri Mondor Hospital-AP-HP
Study officials:
affiliation: Henri Mondor University Hospital
name: Olivier CHOSODOW, Professor
role: PRINCIPAL_INVESTIGATOR
References: