Skin InfectionsNCT03985475
Identification of the Cutaneous Microbiota in Patients With Cutaneous Infection (MICROBIOTA)
An observational study of Skin Infections, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Infections
- What is being tested?
- skin sample
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 1 Jul 2022
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient present meeting the inclusion criteria of the study will be offered to participate in the study.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de maladies Infectieuses
Marseille, Cedex 5, 13354
Philippe PAROLA, philippe.parola@ap-hm.fr
About this study
Official title: 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.
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.
- Conditions
- Skin Infections
- Being tested
- skin sample
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin sampleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: skin sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 36 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start1 Jul 2019 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin InfectionsStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARNAUD, Study director, AP HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985475
- Sponsor's protocol ID
- 2018-57
- Status last verified
- Jun 2019
- First submitted
- 7 Jun 2019
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Cutaneous Microbiota in Patients With Cutaneous Infection Admitted in the Department of Acute Infectious Diseases
- ClinicalTrials.gov ID
- NCT03985475
- Acronym / sponsor ID
- 2018-57
- Conditions
- Skin Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Person with a skin infection | – | Other: skin sampleFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient present meeting the inclusion criteria of the study will be offered to participate in the study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin sampleFor 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 | Person with a skin infection |
Primary outcome
Distribution of microorganisms found according to patient characteristics
Time frame: 36 moths
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,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Olivier ARNAUD study director
AP HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Infections, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Parola (33(0)4 91 38 55 17, philippe.parola@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of microorganisms found according to patient characteristics (time frame: 36 moths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.