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

NCT03976024 | Unknown

• 1 other identifier: APHP180348
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Streptococcus Infection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

• Rate of beta-hemolytic streptococcus in patients living under the same roof as patients with DHBN-FN

  Up to 10 Days

• Main factors of streptococcal virulence

  Day 0, Day 10

Study Arms (2)

DHBN-FN arm

EXPERIMENTAL

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

Control arm (Erysipelas)

ACTIVE COMPARATOR

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)

Interventions

DHBN-FN arm 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

DHBN-FN arm

Control arm (Erysipelas) OTHER

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

Control arm (Erysipelas)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital-AP-HP

Créteil, 94000, France

Location

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Olivier CHOSODOW, Professor

  Henri Mondor University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier CHOSIDOW, Professor

CONTACT

+33(1)49812500; olivier.chosidow@aphp.fr

Camille HUA, Doctor

CONTACT

01 49 87 81 72; camille.hua@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: June 5, 2019
• Study Start: September 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2020
• Last Updated: May 20, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)