Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06095076
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-06-20
Brief Title:
Cutaneous Microbiota Evolution in ICU Patients With CVC ICMc
Sponsor:
Centre Hospitalier de Cayenne
Organization:
Centre Hospitalier de Cayenne
Study Overview
Official Title:
Prospective Descriptive Study of the Cutaneous Microbiota of ICU Patients With Central Venous Catheter ICMc
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICMc
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None