Cutaneous Microbiota Evolution in ICU Patients With CVC (ICMc)

NCT06095076 | Unknown

• 1 other identifier: 2023_006
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Dysbiosis; Catheter-Related Infections

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Skin swabs Metagenomics

  Baseline

• Skin colonization

  Baseline

• Catheter-related colonization

  Baseline

• Central Venous Catheter's Metagenomics

  Baseline

• Catheter related Infection

  Baseline

Interventions

Skin swabbing DIAGNOSTIC_TEST

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 OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Cayenne: lead
• Tropical Biome and ImmunoPhysiopathology (TBIP) - French Guiana University (Université de Guyane): collaborator

Study Sites (1)

Centre Hospitalier de Cayenne

Cayenne, Guyane Française, 97306, French Guiana

RECRUITING

Related Publications (29)

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Related Links

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Skin swab catheter (standard culture)

MeSH Terms

Conditions

Dysbiosis; Catheter-Related Infections; Cross Infection

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Iatrogenic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ariane ROUJANSKY

  Centre Hospitalier de Cayenne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariane ROUJANSKY

CONTACT

+594594395354; ariane.roujansky@ch-cayenne.fr

Hatem KALLEL

CONTACT

+594594395354; hatem.kallel@ch-cayenne.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: October 23, 2023
• Study Start: June 2, 2023
• Primary Completion: December 2, 2023
• Study Completion: June 2, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-05

Locations

FR (1)