Identification of the Cutaneous Microbiota in Patients With Cutaneous Infection (MICROBIOTA)

Identification of the Cutaneous Microbiota in Patients With Cutaneous Infection Admitted in the Department of Acute Infectious Diseases

Identify the cutaneous microbiota on a cutaneous lesion (cellulite, wound, rash, etc.) on a swab, biopsies or abscess puncture and on "healthy" skin on a skin swab performed for cutaneous mapping to search for staphylococcal deposits.

Study Overview

• Status: Unknown
• Conditions: Skin Infections
• Intervention / Treatment: Other: skin sample

Detailed Description

Cellulite is characterized by inflammation and an alleged infection of the skin and subcutaneous tissues. Previous studies have shown a low yield of samples such as biopsy and needle aspiration of the order of 16%. The most common pathogens are Staphylococcus aureus and Streptococcus pyogenes.

Conventional cultivation has limitations such as the lack of detection of fastidious microorganisms, or the use of antibiotics. Molecular diagnostic methods, such as detection of 16S ribosomal DNA followed by amplification and pyrosequencing, have been used to overcome the limitations of microbial culture.

In a recent study, the authors investigated the causes of acute cellulitis without performing drainage but skin biopsies from the infected site and another non-infected site by quantitative PCR, pyrosequencing, and conventional culture. PCR identified methicillin-resistant S. aureus methicillin in approximately 30% -40% of cases with similar frequency in infected and uninfected sites. In another study R. felis was found in not only bedsores, but also, swabs taken from healthy skin, as well as Streptococcus pneumoniae, S. aureus and Streptococcus group A. Being engaged in the exploration of the human microbiota especially by culture we propose to extend the knowledge of this skin microbiota in patients hospitalized in Infectious Disease services.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Philippe Parola; Phone Number: 33(0)4 91 38 55 17; Email: philippe.parola@ap-hm.fr

Study Locations

• France
  • Cedex 5
    • Marseille, Cedex 5, France, 13354
      • Service de maladies Infectieuses
      • Contact: PHILIPPE PAROLA; Email: philippe.parola@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Any patient present meeting the inclusion criteria of the study will be offered to participate in the study.

Description

Inclusion Criteria:

• Patient with skin infections at admission
• Patient requiring skin mapping
• Person informed of the study and having expressed no opposition to participate in the study.
• Affiliate or beneficiary of a social security

Exclusion Criteria:

• Subject not agreeing to participate
• Vulnerable person: pregnant, parturient or nursing woman, person under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Person with a skin infection; For each person included in the study, skin sampling performed as part of the medical management of skin infections will be performed, associated with the contralateral healthy skin sampling.	Other: skin sample; For each person included in the study, skin sampling performed as part of the medical management of skin infections will be performed, associated with the contralateral healthy skin sampling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of microorganisms found according to patient characteristics	Diagnosis by culture with identification by "Maldi tof" on cutaneous samples Molecular diagnosis with specific PCR identification of pathogens: Staphylococcus aureus, Streptococcus A, 16S rRNA and sequencing,	36 moths

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: Jean-Olivier ARNAUD, AP HM

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (Actual): June 13, 2019

Study Record Updates

• Last Update Posted (Actual): June 13, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Inflammation; Disease Attributes; Connective Tissue Diseases; Suppuration; Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious
• Other Study ID Numbers: 2018-57

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No