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

NCT ID: NCT03976024

Last Updated: 2020-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2020-11-01

Brief Summary

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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

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Conditions

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Streptococcus Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

DHBN-FN arm

Intervention Type OTHER

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)

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).

Group Type ACTIVE_COMPARATOR

Control arm (Erysipelas)

Intervention Type OTHER

The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0 (admission).

Interventions

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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

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier CHOSODOW, Professor

Role: PRINCIPAL_INVESTIGATOR

Henri Mondor University Hospital

Locations

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Henri Mondor Hospital-AP-HP

Créteil, , France

Site Status

Countries

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France

Central Contacts

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Olivier CHOSIDOW, Professor

Role: CONTACT

+33(1)49812500

Camille HUA, Doctor

Role: CONTACT

01 49 87 81 72

Facility Contacts

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Olivier CHOSIDOW, pROFESSOR

Role: primary

Camille HUA, Doctor

Role: backup

Other Identifiers

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APHP180348

Identifier Type: -

Identifier Source: org_study_id

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