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

April 27, 2024 updated by: Amira JAMOUSSI, Abderrahmane Mami Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Tunisia
    • Tunis
      • Ariana, Tunis, Tunisia, 2080
        • Recruiting
        • Abderrahmen Mami
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 2 months
Incidence of eHRB healthcare associated infections in ICU
2 months
Epidemiological features of Highly resistant bacterial healthcare associated infections healthcare associated infections in ICU
Time Frame: 2 months
Causative micro-organisms, sites and risk factors of eHRB healthcare associated infections in ICU
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abderrahmane Mami Hospital

Investigators

  • Principal Investigator: Amira JAMOUSSI, Professor, Abderrahmen Mami Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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