NCT03985475

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 13, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

June 13, 2019

Status Verified

June 1, 2019

Enrollment Period

3 years

First QC Date

June 7, 2019

Last Update Submit

June 12, 2019

Conditions

Outcome Measures

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,

    36 moths

Study Arms (1)

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

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.

Person with a skin infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de maladies Infectieuses

Marseille, Cedex 5, 13354, France

Location

MeSH Terms

Conditions

Cellulitis

Condition Hierarchy (Ancestors)

Skin Diseases, InfectiousInfectionsSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Olivier ARNAUD

    AP HM

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2019

First Posted

June 13, 2019

Study Start

July 1, 2019

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

June 13, 2019

Record last verified: 2019-06

Locations