Cross InfectionNOSOREA2NCT05547646
The Prevalence of Healthcare-associated Infection in Medical Intensive Care Units in Tunisia
An observational study of Cross Infection and Prevalence, run by Abderrahmane Mami Hospital at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cross Infection, Prevalence, Epidemiology
- How many people
- 120 participants
- Where
- 1 siteTunisia
- Study dates
- 27 Sep 2022to 28 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: One-day point-prevalence study (September 27th, 2022) All medical ICUs across Tunisia are invited to participate, excluding cardiologic and paediatric care units. All patients occupying an ICU bed over a 48-hour period are eligible.
Who may be able to join
- All patients occupying an ICU bed over a 48-hour period
- Age >=18 years
Who cannot join
- no criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence of Healthcare-associated Infection in Medical Intensive Care Units in Tunisia: NOSOREA2 Study
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.
Read the 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.
- Conditions
- Cross Infection, Prevalence, Epidemiology, Critical Care
- Keywords
- Iatrogenic Disease, Cross Infection, Intensive Care Units, Prevalence, Risk Factors, Critical Care
- Medical subject headings
- Cross Infection, Iatrogenic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: September 27th, 2022
Secondary outcomes (1)
Identify independent risk factors of HAIs.
Multivariate logistic regression model
Measured: September 27th, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start27 Sep 2022
- Primary completion28 Sep 2022
- Study completion28 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cross InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abderrahmane Mami Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira JAMOUSSI, Abderrahmane Mami Hospital
- Investigators
- Amira JAMOUSSI, pROFESSOR, Principal investigator, Ministery of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547646
- Sponsor's protocol ID
- 1
- Acronym
- NOSOREA2
- Status last verified
- Aug 2023
- First submitted
- 1 Sep 2022
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Healthcare-associated Infection in Medical Intensive Care Units in Tunisia: NOSOREA2 Study
- ClinicalTrials.gov ID
- NCT05547646
- Acronym / sponsor ID
- NOSOREA2 / 1
- Conditions
- Cross Infection, Prevalence, Epidemiology, Critical Care
- Keywords
- Iatrogenic Disease, Cross Infection, Intensive Care Units, Prevalence, Risk Factors, Critical Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Abderrahmane Mami HospitalUniversity, hospital or other
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One-day point-prevalence study (September 27th, 2022) All medical ICUs across Tunisia are invited to participate, excluding cardiologic and paediatric care units. All patients occupying an ICU bed over a 48-hour period are eligible.
Key inclusion criteria (2 listed)
- All patients occupying an ICU bed over a 48-hour period
- Age >=18 years
Key exclusion criteria (1 listed)
- no criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the prevalence of healthcare-associated infection in medical Tunisian ICUs
Time frame: September 27th, 2022
The number of infected patients divided by the total number of patients at the day of the study
1 secondary outcome
Identify independent risk factors of HAIs.
Time frame: September 27th, 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amira JAMOUSSI, pROFESSOR principal investigator
Ministery of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cross Infection and Prevalence, run by Abderrahmane Mami Hospital at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the prevalence of healthcare-associated infection in medical Tunisian ICUs (time frame: September 27th, 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.