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NOSOREA2: The Prevalence of Healthcare-associated Infection in Medical Intensive Care Units in Tunisia

Sponsor
Abderrahmane Mami Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05547646
Collaborator
(none)
120
Enrollment
1
Location
1
Anticipated Duration (Days)
3652.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We aimed to determine the prevalence of HAI in medical Tunisian ICUs. Secondary endpoints were to identify the predominant infecting microorganisms and evaluate independent risk factors of HAIs.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In Tunisia, there is no national or regional monitoring system of HAI. It is worth noting that HCAIs in intensive care unit (ICU) are more common and life threatening than in general ward because of the frequent use of invasive procedures and multiple therapies.

    Controlling this fatal scourge should begin with greater awareness of HAI frequency and ICU ecology. That is why conducting multi-center Tunisian studies is necessary to guide control measurements against HAI and to improve surveillance and infection-control practices. NOSOREA1 study (Tunis Med. 2018 Oct-Nov;96(10-11):731-736) was conducted in 2017 and showed that HAI prevalence within Tunisian ICUs was 25.2% CI 95% [15-35]. Five years later, it is high time to update our finding.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Prevalence of Healthcare-associated Infection in Medical Intensive Care Units in Tunisia: NOSOREA2 Study
    Anticipated Study Start Date :
    Sep 27, 2022
    Anticipated Primary Completion Date :
    Sep 28, 2022
    Anticipated Study Completion Date :
    Sep 28, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Determine the prevalence of healthcare-associated infection in medical Tunisian ICUs [September 27th, 2022]

      The number of infected patients divided by the total number of patients at the day of the study

    Secondary Outcome Measures

    1. Identify independent risk factors of HAIs. [September 27th, 2022]

      Multivariate logistic regression model

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • All patients occupying an ICU bed over a 48-hour period

    • Age >=18 years

    Exclusion Criteria:
    • no criteria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical ICU Tunis Ariana Tunisia 2080

    Sponsors and Collaborators

    • Abderrahmane Mami Hospital

    Investigators

    • Principal Investigator: Amira JAMOUSSI, pROFESSOR, Ministery of Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amira JAMOUSSI, Dr Associate Professor, Abderrahmane Mami Hospital
    ClinicalTrials.gov Identifier:
    NCT05547646
    Other Study ID Numbers:
    • 1
    First Posted:
    Sep 21, 2022
    Last Update Posted:
    Sep 21, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amira JAMOUSSI, Dr Associate Professor, Abderrahmane Mami Hospital
    Iatrogenic Disease
    Cross Infection
    Intensive Care Units
    Prevalence
    Risk Factors
    Critical Care
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Cross Infection

    Study Results

    No Results Posted as of Sep 21, 2022