Cutaneous Microbiota Evolution in ICU Patients With CVC (ICMc)

Dysbiosis Clinical Trial

— ICMc  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06095076
• Other study ID #: 2023_006
• Status: Recruiting
• Start date: June 2, 2023
• Est. completion date: June 2, 2024

Study information

• Verified date: May 2023
• Source: Centre Hospitalier de Cayenne
• Contact: Ariane ROUJANSKY
• Phone: +594594395354
• Email: ariane.roujansky[@]ch-cayenne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2, 2024
• Est. primary completion date: December 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter-Related Infections
• Dysbiosis
• Infections

Intervention

Diagnostic Test:
• Skin 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.

Other:
• Data collection
General patient characteristics and informations relative to CVC infection and treatment will be collected.

Locations

Country	Name	City	State
French Guiana	Centre Hospitalier de Cayenne	Cayenne	Guyane Française

Sponsors (2)

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

Country where clinical trial is conducted

French Guiana, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

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

External Links

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