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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05547646
Other study ID # 1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 27, 2022
Est. completion date September 28, 2022

Study information

Verified date August 2023
Source Abderrahmane Mami Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date September 28, 2022
Est. primary completion date September 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients occupying an ICU bed over a 48-hour period - Age >=18 years Exclusion Criteria: - no criteria

Study Design


Locations

Country Name City State
Tunisia Medical ICU Tunis Ariana

Sponsors (1)

Lead Sponsor Collaborator
Abderrahmane Mami Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine the prevalence of healthcare-associated infection in medical Tunisian ICUs The number of infected patients divided by the total number of patients at the day of the study September 27th, 2022
Secondary Identify independent risk factors of HAIs. Multivariate logistic regression model September 27th, 2022
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