Epidemiological Features of Emergent Highly Resistant Bacteria in Tunisian Intensive Care Units (NOSOREA3)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Cross Infection; Vancomycin-Resistant Enterococcal Infection; Carbapenem Resistant Bacterial Infection
• Intervention / Treatment: Other: epidemiological records

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Amira JAMOUSSI, Professor; Phone Number: +21698375250; Email: amira.jamoussi@fmt.utm.tn
• Study Contact Backup: Name: Jalila BEN KHELIL, Professor; Phone Number: +21653689799; Email: jalila.benkhelil@fmt.utm.tn

Study Locations

• Tunisia
  • Tunis
    • Ariana, Tunis, Tunisia, 2080
      • Recruiting
      • Abderrahmen Mami
      • Contact: JAMOUSSI Amira, Pr; Phone Number: +21698375250; Email: amira.jamoussi@fmt.utm.tn
      • Sub-Investigator: Asma MAHDI, Dr
      • Sub-Investigator: Inès SEDGHIANI, Dr
      • Sub-Investigator: Inès FATHALLAH, Dr
      • Sub-Investigator: Hassen BEN GHEZALA, Dr
      • Sub-Investigator: Lilya DEBBICHE, Dr
      • Sub-Investigator: Khaoula BEN ISMAIL, Dr
      • Sub-Investigator: Hend ALLOUCHE, Dr
      • Sub-Investigator: Radhouane TOUMI, Dr
      • Sub-Investigator: Sana KHARRAT, Dr
      • Sub-Investigator: Fatma KAANICHE, Dr
      • Sub-Investigator: Hager NOUIRA, Dr
      • Sub-Investigator: Manel LAHMER, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult ICU patients admitted during the study period

Description

Inclusion Criteria:

• Adult ICU patients admitted during the study period

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
eHDR+; Patients with Emergent Highly Resistant Bacteria healthcare associated infection	Other: epidemiological records; Healthcare associated infections due to emergent highly resistant bacteria, sites, risk factors, treatment and outcome
eHDR-; Patients without Emergent Highly Resistant Bacteria healthcare associated infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Highly resistant bacterial healthcare associated infections	Incidence of eHRB healthcare associated infections in ICU	2 months
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

Collaborators and Investigators

• Sponsor: Abderrahmane Mami Hospital
• Investigators: Principal Investigator: Amira JAMOUSSI, Professor, Abderrahmen Mami Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: March 30, 2024
• First Submitted That Met QC Criteria: April 27, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 27, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Critical care; Drug resistance; Healthcare Associated Infections
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Iatrogenic Disease; Infections; Communicable Diseases; Critical Illness; Bacterial Infections; Cross Infection
• Other Study ID Numbers: ATR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No