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

Streptococcus Infection Clinical Trial

— STREPTO-FAST  

Official title:

Necrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis (DHBN-FN) Mono- or Multi-microbial Streptococcus Beta-haemolytic: Study of Carriage in Patients and Their Entourage

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03976024
• Other study ID #: APHP180348
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: December 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Olivier CHOSIDOW, Professor
• Phone: +33(1)49812500
• Email: olivier.chosidow[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Necrotizing
• Streptococcal Infections
• Streptococcus Infection

Intervention

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

Locations

Country	Name	City	State
France	Henri Mondor Hospital-AP-HP	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Prevalence of SBH carriage at the time of diagnosis		Day 0, Day 10
Secondary	Sites of SBH carriage at the time of diagnosis		Day 0, Day 10
Secondary	Rate of beta-hemolytic streptococcus in patients with erysipelas	The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0.	Day 0
Secondary	Rate of beta-hemolytic streptococcus in patients living under the same roof as patients with DHBN-FN	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.	Up to 10 Days
Secondary	Main factors of streptococcal virulence	Analyze the main factors of streptococcal virulence by Streptococcal genome sequencing	Day 0, Day 10