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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03976024
Acronym
STREPTO-FAST
Enrollment
100
Registered
2019-06-05
Start date
2020-09-01
Completion date
2020-11-01
Last updated
2020-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Streptococcus Infection

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.

Interventions

OTHERDHBN-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

OTHERControl arm (Erysipelas)

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of beta-hemolytic streptococcus in patients with DHBN-FNDay 0Evaluation 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

Secondary

MeasureTime frameDescription
Prevalence of SBH carriage at the time of diagnosisDay 0, Day 10
Sites of SBH carriage at the time of diagnosisDay 0, Day 10
Rate of beta-hemolytic streptococcus in patients with erysipelasDay 0The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0.
Rate of beta-hemolytic streptococcus in patients living under the same roof as patients with DHBN-FNUp to 10 DaysThe 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.
Main factors of streptococcal virulenceDay 0, Day 10Analyze the main factors of streptococcal virulence by Streptococcal genome sequencing

Countries

France

Contacts

Primary ContactOlivier CHOSIDOW, Professor
olivier.chosidow@aphp.fr+33(1)49812500
Backup ContactCamille HUA, Doctor
camille.hua@aphp.fr01 49 87 81 72

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026