Cutaneous Microbiota Evolution in ICU Patients With CVC (ICMc) (ICMc)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Dysbiosis; Catheter-Related Infections
• Intervention / Treatment: Diagnostic test: Skin swabbing; Other: Data collection

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)

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Ariane ROUJANSKY; Phone Number: +594594395354; Email: ariane.roujansky@ch-cayenne.fr
• Study Contact Backup: Name: Hatem KALLEL; Phone Number: +594594395354; Email: hatem.kallel@ch-cayenne.fr

Study Locations

• French Guiana
  • Guyane Française
    • Cayenne, Guyane Française, French Guiana, 97306
      • Recruiting
      • Centre Hospitalier de Cayenne
      • Contact: Ariane ROUJANSKY, Dr; Phone Number: 53 54 +594 594 39 53 54; Email: ariane.roujansky@ch-cayenne.fr
      • Contact: Hatem KALLEL, PhD; Email: hatem.kallel@ch-cayenne.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of alpha-diversity	Comparison 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.	Baseline
Evolution of alpha-diversity	Comparison 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.	Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin swabs Metagenomics	Metagenomics: Alpha and beta-diversity of skin swabs	Baseline
Skin colonization	Skin colonization: positive standard culture of skin swabs	Baseline
Catheter-related colonization	Catheter-related colonization: standard central line culture positivity	Baseline
Central Venous Catheter's Metagenomics	Metagenomics: alpha and beta-diversity of Central Venous Catheter at removal	Baseline
Catheter related Infection	Clinical signs and blood culture and/or positive catheter culture	Baseline
Skin swabs Metagenomics	Comparison 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.	Day 3
Skin colonization	Skin colonization: positive standard culture of skin swabs	Day 3
Catheter-related colonization	Catheter-related colonization: standard central line culture positivity	Day 3
Central Venous Catheter's Metagenomics	Metagenomics: alpha and beta-diversity of Central Venous Catheter at removal	Day 3
Catheter related Infection	Clinical signs and blood culture and/or positive catheter culture	Day 3

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Cayenne
• Collaborators: Tropical Biome and ImmunoPhysiopathology (TBIP) - French Guiana University (Université de Guyane)
• Investigators: Principal Investigator: Ariane ROUJANSKY, Centre Hospitalier de Cayenne

Publications and helpful links

General Publications

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• Chen HS, Wang FD, Lin M, Lin YC, Huang LJ, Liu CY. Risk factors for central venous catheter-related infections in general surgery. J Microbiol Immunol Infect. 2006 Jun;39(3):231-6.
• Timsit JF. [Updating of the 12th consensus conference of the Societe de Reanimation de langue francaise (SRLF): catheter related infections in the intensive care unit]. Ann Fr Anesth Reanim. 2005 Mar;24(3):315-22. doi: 10.1016/j.annfar.2004.12.022. French.
• Grice EA, Kong HH, Conlan S, Deming CB, Davis J, Young AC; NISC Comparative Sequencing Program; Bouffard GG, Blakesley RW, Murray PR, Green ED, Turner ML, Segre JA. Topographical and temporal diversity of the human skin microbiome. Science. 2009 May 29;324(5931):1190-2. doi: 10.1126/science.1171700.
• Tacconelli E, Smith G, Hieke K, Lafuma A, Bastide P. Epidemiology, medical outcomes and costs of catheter-related bloodstream infections in intensive care units of four European countries: literature- and registry-based estimates. J Hosp Infect. 2009 Jun;72(2):97-103. doi: 10.1016/j.jhin.2008.12.012. Epub 2009 Feb 25.
• Soufir L, Timsit JF, Mahe C, Carlet J, Regnier B, Chevret S. Attributable morbidity and mortality of catheter-related septicemia in critically ill patients: a matched, risk-adjusted, cohort study. Infect Control Hosp Epidemiol. 1999 Jun;20(6):396-401. doi: 10.1086/501639.
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• Byrd AL, Belkaid Y, Segre JA. The human skin microbiome. Nat Rev Microbiol. 2018 Mar;16(3):143-155. doi: 10.1038/nrmicro.2017.157. Epub 2018 Jan 15.
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Helpful Links

• Santé Publique France- Mission Nationale SPIADI. Surveillance des infections associées aux dispositifs invasifs. Mission nationale SPIADI. Résultats de la surveillance menée en 2019.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2023
• Primary Completion (Estimated): December 2, 2023
• Study Completion (Estimated): June 2, 2024

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Microbiota; Catheter-related infections; Healthcare associated infection; Cutaneous microbiota
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Catheter-Related Infections; Dysbiosis
• Other Study ID Numbers: 2023_006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No