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Trial record 8 of 16 for:    Necrotizing Fascitis

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

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ClinicalTrials.gov Identifier: NCT03976024
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Streptococcus Infection Other: DHBN-FN arm Other: Control arm (Erysipelas) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Necrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis (DHBN-FN) Mono- or Multi-microbial Streptococcus Beta-haemolytic: Study of Carriage in Patients and Their Entourage
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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

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

Active Comparator: 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).

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).




Primary Outcome Measures :
  1. Rate of beta-hemolytic streptococcus in patients with DHBN-FN [ Time Frame: Day 0 ]
    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

  2. Rate of beta-hemolytic streptococcus in patients with DHBN-FN [ Time Frame: 1 month after hospitalization discharge ]
    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

  3. Rate of beta-hemolytic streptococcus in patients with DHBN-FN [ Time Frame: Day 30 ]
    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


Secondary Outcome Measures :
  1. Prevalence of SBH carriage at the time of diagnosis [ Time Frame: Day 0, Day 10 ]
  2. Sites of SBH carriage at the time of diagnosis [ Time Frame: Day 0, Day 10 ]
  3. Rate of beta-hemolytic streptococcus in patients with erysipelas [ Time Frame: Day 0 ]
    The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0.

  4. Rate of beta-hemolytic streptococcus in patients living under the same roof as patients with DHBN-FN [ Time Frame: Up to 10 Days ]
    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.

  5. Main factors of streptococcal virulence [ Time Frame: Day 0, Day 10 ]
    Analyze the main factors of streptococcal virulence by Streptococcal genome sequencing



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976024


Contacts
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Contact: Olivier CHOSIDOW, Professor +33(1)49812500 olivier.chosidow@aphp.fr
Contact: Camille HUA, Doctor 01 49 87 81 72 camille.hua@aphp.fr

Locations
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France
Henri Mondor Hospital-AP-HP Not yet recruiting
Créteil, France, 94000
Contact: Olivier CHOSIDOW, pROFESSOR         
Contact: Camille HUA, Doctor         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Olivier CHOSODOW, Professor Henri Mondor Hospital

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03976024     History of Changes
Other Study ID Numbers: APHP180348
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Necrotizing
Streptococcal Infections
Musculoskeletal Diseases
Skin Diseases, Bacterial
Bacterial Infections
Gram-Positive Bacterial Infections