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

A

Assistance Publique - Hôpitaux de Paris

Status

Unknown

Conditions

Streptococcus Infection

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03976024
APHP180348

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

DHBN-FN arm
Experimental group
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
Treatment:
Other: DHBN-FN arm
Control arm (Erysipelas)
Active Comparator group
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).
Treatment:
Other: Control arm (Erysipelas)

Trial contacts and locations

1

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Central trial contact

Olivier CHOSIDOW, Professor; Camille HUA, Doctor

Data sourced from clinicaltrials.gov

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