Clinical trial NCT06095076: Cutaneous Microbiota Evolution in ICU Patients With CVC (ICMc)
Official title: Prospective Descriptive Study of the Cutaneous Microbiota of ICU Patients With Central Venous Catheter (ICMc)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dysbiosis
Catheter-Related Infections
Keywords: Microbiota
Cutaneous microbiota
Healthcare associated infection
Catheter-related infections
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
Collaborators: name: Tropical Biome and ImmunoPhysiopathology (TBIP) - French Guiana University (Université de Guyane)
First posted: 2023-10-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult hospitalized in ICU at the Cayenne Hospital Center in whom the installation of a CVC is indicated

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)

Eligibility criteria: 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

Primary outcomes:
measure: Evolution of alpha-diversity
timeFrame: Baseline
measure: Evolution of alpha-diversity
timeFrame: Day 3
Secondary outcomes:
measure: Skin swabs Metagenomics
timeFrame: Baseline
measure: Skin colonization
timeFrame: Baseline
measure: Catheter-related colonization
timeFrame: Baseline
measure: Central Venous Catheter's Metagenomics
timeFrame: Baseline
measure: Catheter related Infection
timeFrame: Baseline
measure: Skin swabs Metagenomics
timeFrame: Day 3
measure: Skin colonization
timeFrame: Day 3
measure: Catheter-related colonization
timeFrame: Day 3
measure: Central Venous Catheter's Metagenomics
timeFrame: Day 3
measure: Catheter related Infection
timeFrame: Day 3
Other outcomes:
Locations:
city: Cayenne
country: French Guiana
facility: Centre Hospitalier de Cayenne
state: Guyane Française
Study officials:
affiliation: Centre Hospitalier de Cayenne
name: Ariane ROUJANSKY
role: PRINCIPAL_INVESTIGATOR
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