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Cutaneous Microbiota Evolution in ICU Patients With CVC (ICMc)

Prospective Descriptive Study of the Cutaneous Microbiota of ICU Patients With Central Venous Catheter (ICMc)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06095076
Acronym
ICMc
Enrollment
120
Registered
2023-10-23
Start date
2023-06-02
Completion date
2024-06-02
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter-Related Infections, Dysbiosis

Keywords

Microbiota, Cutaneous microbiota, Healthcare associated infection, Catheter-related infections

Brief summary

Intensive Care Unit (ICU) patients are exposed to catheter-related infections with an important morbidity. Catheter colonization is constant but infection is not. Cutaneous dysbiosis could be the missing link. Our study aims to evaluate the evolution of cutaneous microbiota in ICU patients with a central venous catheter in place, through metagenomics. Our main objective is to evaluate the evolution of alpha-diversity, quantified by intra-patient variation of Shannon diversity index (a diversity index used in bacterial metagenomics).

Detailed description

Central venous catheters (CVCs) are necessary in up to 60% of ICU patients, representing a risk of catheter-related infections with high morbidity and mortality. Catheter colonization originating mostly from the skin is constant, but infection is not. Dysbiosis is known to be associated with pathological states and infection, for example post-antibiotic C. difficile diarrheas, or atopic dermatitis, in which flares are associated with dysbiosis and S. aureus predominance. Cutanous dysbiosis could be the missing link between catheter colonization and infection. Our hypothesis is that under the influence of multiple ICU factors (stress, antibiotic administration, local dysinfection procedures), cutaneous dybiosis appears in ICU patients with a central venous catheter. 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)

Interventions

DIAGNOSTIC_TESTSkin 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.

OTHERData collection

General patient characteristics and informations relative to CVC infection and treatment will be collected.

Sponsors

Tropical Biome and ImmunoPhysiopathology (TBIP) - French Guiana University (Université de Guyane)
CollaboratorUNKNOWN
Centre Hospitalier de Cayenne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

\- Adult hospitalized in ICU at the Cayenne Hospital Center in whom the installation of a CVC is indicated

Exclusion criteria

* Patient under 18 years of age * 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

Design outcomes

Primary

MeasureTime frameDescription
Evolution of alpha-diversityBaselineComparison of Shannon index at various time points with baseline Shannon index (before Central Venous Catheter placement through leaving intensive care service). The higher the Shannon index, the greater the diversity.

Secondary

MeasureTime frameDescription
Skin swabs MetagenomicsBaselineMetagenomics: Alpha and beta-diversity of skin swabs
Skin colonizationBaselineSkin colonization: positive standard culture of skin swabs
Catheter-related colonizationBaselineCatheter-related colonization: standard central line culture positivity
Central Venous Catheter's MetagenomicsBaselineMetagenomics: alpha and beta-diversity of Central Venous Catheter at removal
Catheter related InfectionBaselineClinical signs and blood culture and/or positive catheter culture

Countries

French Guiana

Contacts

Primary ContactAriane ROUJANSKY
ariane.roujansky@ch-cayenne.fr+594594395354
Backup ContactHatem KALLEL
hatem.kallel@ch-cayenne.fr+594594395354

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026