Cutaneous Microbiota Evolution in ICU Patients With CVC (ICMc)
NCT ID: NCT06095076
Last Updated: 2023-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2023-06-02
2024-06-02
Brief Summary
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Detailed Description
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All adult ICU patients with an indication for CVC placement will be included over a 6 months period. Skin swabbing will be performed on CVC insertion site before CVC placement (baseline), and then every 3 days (or when dressing is changed) while CVC is in place, then at ICU discharge. Bacterial metagenomics using bacterial DNA extraction, 16S PCR amplification and Nanopore sequencing will allow for description of cutaneous microbiota and diversity evaluation through Shannon index. Evolution of alpha-diversity will be evaluated through time-series data analysis: comparison of Shannon index at various time points with baseline Shanonn index (before CVC placement). Standard microbiologic culture of skin swabbing will be performed. General patient characteristics and informations relative to CVC infection and treatment will be collected.
This study will have no impact on patient management.
Category 3 Non-Interventional Human Person Research (RIPH 3)
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Skin swabbing
Skin swabbing will be performed on CVC insertion site before CVC placement (baseline), and then every 3 days (or when dressing is changed) while CVC is in place, then at ICU discharge. Bacterial metagenomics using bacterial DNA extraction, 16S PCR amplification and Nanopore sequencing will allow for description of cutaneous microbiota and diversity evaluation through Shannon index. Evolution of alpha-diversity will be evaluated through time-series data analysis: comparison of Shannon index at various time points with baseline Shanonn index (before CVC placement). Standard microbiologic culture of skin swabbing will be performed.
Data collection
General patient characteristics and informations relative to CVC infection and treatment will be collected.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patient or trusted person or family or relative objecting to participation in the study (refusal)
* Patient under judicial safeguard or under any other protective regime (guardianship or curatorship)
* Patient with cutaneous lesions (infection, burn) near the cutaneous insertion site of the CVC
18 Years
ALL
Yes
Sponsors
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Tropical Biome and ImmunoPhysiopathology (TBIP) - French Guiana University (Université de Guyane)
UNKNOWN
Centre Hospitalier de Cayenne
OTHER
Responsible Party
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Principal Investigators
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Ariane ROUJANSKY
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier de Cayenne
Locations
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Centre Hospitalier de Cayenne
Cayenne, Guyane Française, French Guiana
Countries
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Central Contacts
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Facility Contacts
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References
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Related Links
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Santé Publique France- Mission Nationale SPIADI. Surveillance des infections associées aux dispositifs invasifs. Mission nationale SPIADI. Résultats de la surveillance menée en 2019.
Other Identifiers
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2023_006
Identifier Type: -
Identifier Source: org_study_id
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