Cross InfectionNOSOREA3NCT06392568
Epidemiological Features of Emergent Highly Resistant Bacteria in Tunisian Intensive Care Units
An observational study of Cross Infection and Carbapenem Resistant Bacterial Infection, run by Abderrahmane Mami Hospital at 1 site in Tunisia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cross Infection, Carbapenem Resistant Bacterial Infection, Vancomycin-Resistant Enterococcal Infection
- What is being tested?
- epidemiological records
- How many people
- 500 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Apr 2024to 31 May 2024
- 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: Adult ICU patients admitted during the study period
Who may be able to join
- Adult ICU patients admitted during the study period
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Abderrahmen Mami
Ariana, Tunis Governorate, 2080
JAMOUSSI Amira, Pr, +21698375250, amira.jamoussi@fmt.utm.tn
Asma MAHDI, Dr
About this study
Official title: 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.
Read the 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.
- Conditions
- Cross Infection, Carbapenem Resistant Bacterial Infection, Vancomycin-Resistant Enterococcal Infection, Critical Illness
- Being tested
- epidemiological records
- Keywords
- Critical care, Healthcare Associated Infections, Drug resistance
- Medical subject headings
- Cross Infection, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidemiological recordsOther
Healthcare associated infections due to emergent highly resistant bacteria, sites, risk factors, treatment and outcome
| Study group | Role | What they receive |
|---|---|---|
| eHDR+ | Patients with Emergent Highly Resistant Bacteria healthcare associated infection Receives: Other: epidemiological records | |
| eHDR- | Patients without Emergent Highly Resistant Bacteria healthcare associated infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highly resistant bacterial healthcare associated infections
Incidence of eHRB healthcare associated infections in ICU
Measured: 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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Apr 2024
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
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
- Prospective
- Enrolment
- 500 participants (estimated)
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, Abderrahmen Mami Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392568
- Sponsor's protocol ID
- ATR
- Acronym
- NOSOREA3
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2024
- Last updated
- 30 Apr 2024
- 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Features of Emergent Highly Resistant Bacteria in Tunisian Intensive Care Units: A Prospective Multicenter National Observational Study (NOSOREA-3)
- ClinicalTrials.gov ID
- NCT06392568
- Acronym / sponsor ID
- NOSOREA3 / ATR
- Conditions
- Cross Infection, Carbapenem Resistant Bacterial Infection, Vancomycin-Resistant Enterococcal Infection, Critical Illness
- Keywords
- Critical care, Healthcare Associated Infections, Drug resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Abderrahmane Mami HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 30 Apr 2024 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eHDR+ | – | Other: epidemiological recordsPatients with Emergent Highly Resistant Bacteria healthcare associated infection |
| eHDR- | – | –Patients without Emergent Highly Resistant Bacteria healthcare associated infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU patients admitted during the study period
Key inclusion criteria (1 listed)
- Adult ICU patients admitted during the study period
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epidemiological recordsHealthcare associated infections due to emergent highly resistant bacteria, sites, risk factors, treatment and outcome | Other | eHDR+ |
Primary outcome
Highly resistant bacterial healthcare associated infections
Time frame: 2 months
Incidence of eHRB healthcare associated infections in ICU
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- 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
Abderrahmen Mami Hospital
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 Carbapenem Resistant Bacterial Infection, 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 1 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira JAMOUSSI, Professor (+21698375250, amira.jamoussi@fmt.utm.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Highly resistant bacterial healthcare associated infections (time frame: 2 months). The study lists 2 primary outcomes in all. 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 30 Apr 2024.