Cutaneous Microbiota Evolution in ICU Patients With CVC (ICMc)

Recruiting

• Conditions: Catheter-Related Infections; Dysbiosis

• Registration Number: NCT06095076
• Lead Sponsor: Centre Hospitalier de Cayenne

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)

Study Timeline

• Status Verified: 2023-05
• Study Start: 2023-06-02
• Study First Submitted: 2023-06-20
• Study First Submitted QC: 2023-10-20
• Last Update Submitted: 2023-10-20
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Primary Completion: 2023-12-02
• Study Completion: 2024-06-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evolution of alpha-diversity	Day 3	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier de Cayenne; 🇬🇫 Cayenne, Guyane Française, French Guiana