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NCT06392568 Clinical Trial

Epidemiological Features of Emergent Highly Resistant Bacteria in Tunisian Intensive Care Units

Critical Illness Clinical Trial

— NOSOREA3  

Official title:
Epidemiological Features of Emergent Highly Resistant Bacteria in Tunisian Intensive Care Units: A Prospective Multicenter National Observational Study (NOSOREA-3)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06392568
Other study ID # ATR
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date May 31, 2024

Study information
Verified date April 2024
Source Abderrahmane Mami Hospital
Contact Amira JAMOUSSI, Professor
Phone +21698375250
Email amira.jamoussi@fmt.utm.tn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Investigate the epidemiology, risk factors and impact on clinical practice of healthcare-associated infections with emergent highly drug-resistant (eHDR) pathogens, particularly carbapenem resistant enterobacteriaceae and glycopeptides-resistant enterococcus.

Description:

In 2022, a previous one-day point-prevalence multicenter study (NOSOREA2, NCT05547646) showed that most prevalent pathogens causing healthcare-associated infections were carbapenem resistant enterobacteriaceae. In 2017, (NOSOREA1, LA TUNISIE MEDICALE - 2018 ; Vol 96 (10/11)), most prevalent pathogens were non-fermenting pathogens. Faced with this major epidemiological change within Tunisian ICUs, we decided to launch a 3rd survey under the aegis of the 'Association tunisienne de réanimation'. We aimed to investigate the epidemiology, risk factors and impact on clinical practice of healthcare-associated infections with emergent highly drug-resistant (eHDR) pathogens, particularly carbapenem resistant enterobacteriaceae and glycopeptides-resistant enterococcus. So we conducted a multicenter prospective collection that will take place over 2 months.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult ICU patients admitted during the study period Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• epidemiological records
Healthcare associated infections due to emergent highly resistant bacteria, sites, risk factors, treatment and outcome

Locations
Country Name City State
Tunisia Abderrahmen Mami Ariana Tunis

Sponsors (1)
Lead Sponsor Collaborator
Abderrahmane Mami Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Highly resistant bacterial healthcare associated infections Incidence of eHRB healthcare associated infections in ICU 2 months
Primary Epidemiological features of Highly resistant bacterial healthcare associated infections healthcare associated infections in ICU Causative micro-organisms, sites and risk factors of eHRB healthcare associated infections in ICU 2 months
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