CClinicalTrials.gg
Status unknownNCT03985475Updated Jun 13, 2019

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

An observational study in Skin Infections, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-13.

Sponsored by Assistance Publique Hopitaux De Marseille · Observational

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 100 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
36 Months
Patient registry
Yes

Groups and cohorts

  • 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

Interventions

  • Otherskin 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.

06

What researchers measure

Primary outcomes

  1. 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,

    Time frame: 36 moths

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03985475
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Jun 13, 2019
Start date
Jul 1, 2019 (estimated)
Primary completion
Jul 1, 2022 (estimated)
Completion
Jul 1, 2022 (estimated)
Last update
Jun 13, 2019

Study contacts

Philippe Parola
Contact
philippe.parola@ap-hm.fr
33(0)4 91 38 55 17
Jean-Olivier ARNAUD
study director · AP HM

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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