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

Skin Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03985475
• Other study ID #: 2018-57
• Status: Not yet recruiting
• Start date: July 1, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: June 2019
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Philippe Parola
• Phone: 33(0)4 91 38 55 17
• Email: philippe.parola[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cellulitis
• Communicable Diseases
• Infection
• Skin Diseases, Infectious
• Skin Infections

Intervention

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.

Locations

Country	Name	City	State
France	Service de maladies Infectieuses	Marseille	Cedex 5

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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