ElderlyPREMSNCT04579094
Prevalence and Risk Factors for the Carriage of Bacteria and Clostridioid in Elderly Dependent Persons
An observational study of Elderly and Healthcare Associated Infection, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Brief summary : Very few studies have evaluated the prevalence of multi-drug resistant (MDR), highly resistant emerging bacteria and Clostridioides difficile toxinogenic (CDt) in residents and in healthcare workers (HCW) in nursing home (NH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elderly, Healthcare Associated Infection
- What is being tested?
- Feces sampling at inclusion (J0)
- How many people
- 492 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2022to 30 Sep 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: The target population of the study is all elderly residents of nursing home and their caregivers. The source population of the study corresponds to the residents of the 61 nursing home in the Gard region, and their caregivers.
Who may be able to join
- Resident :
- The resident must be a member or beneficiary of a health insurance. The resident is in permanent accommodation whose the date of admission is at least 1 month earlier on the day of collection.
- healthcare workers : The healthcare workers must be a member or beneficiary of a health insurance. The healthcare workers begin to work in nursing at least 1 month earlier on the day of collection.
Who cannot join
- Resident :
- The resident refuses to participate.
- o healthcare workers : The healthcare workers refuses to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Risk Factors for the Carriage of Multi- and Highly Resistant Bacteria and Clostridioid Difficile Toxigenic in Residents and Healthcare Workers in Nursing Home (PREMS)
Brief summary : Very few studies have evaluated the prevalence of multi-drug resistant (MDR), highly resistant emerging bacteria and Clostridioides difficile toxinogenic (CDt) in residents and in healthcare workers (HCW) in nursing home (NH). Most of study were conducted in acute care services and were limited to specific bacterial species.
Hypothesis : The carriage of MDR bacteria in resident may be a risk factor for an outbreak in NH or in healthcare facility.
Read more
Primary outcome: The objective of this study is to estimate the prevalence for carriage of MDR bacteria and CDt in residents in NH.
Secondary outcomes:
- Estimate the prevalence for carriage of MDR bacteria and CDt toxigenic in HCW in NH.
- Identify the risk factors for carriage of MDR bacteria and CDt in residents in nursing home
- Identify the risk factors for carriage of MDR bacteria and CDt in healthcare workers in NH
- Evaluate the presence of cross-transmission of MDR bacteria and CDt in one or several NH
- Evaluate the association between the presence of cross-transmission of MDR bacteria and CDt in a NH and the management of infection control
- Establishment a collection of stool samples
- Conditions
- Elderly, Healthcare Associated Infection
- Being tested
- Feces sampling at inclusion (J0)
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feces sampling at inclusion (J0)Other
Feces sampling at inclusion (J0)
| Study group | Role | What they receive |
|---|---|---|
| 1/elderly dependent persons | Not described Receives: Other: Feces sampling at inclusion (J0) | |
| 2/healthcare workers (HCW) | Not described Receives: Other: Feces sampling at inclusion (J0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of multi-drug resistant bacteria in residents' feces.
prevalence of carriage of multi-drug resistant bacteria
Measured: at inclusion (J0)
Presence or absence of Highly Resistant and Emerging Bacteria in residents' feces.
prevalence of carriage of Highly Resistant and Emerging Bacteria
Measured: at inclusion (J0)
Presence or absence of Clostridioids difficult toxinogenic in residents' feces.
prevalence of carriage of Clostridioids difficult toxinogenic
Measured: at inclusion (J0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start25 May 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579094
- Sponsor's protocol ID
- LOCAL/2019/JO-01
- Acronym
- PREMS
- Status last verified
- May 2025
- First submitted
- 1 Oct 2020
- Last updated
- 28 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors for the Carriage of Multi- and Highly Resistant Bacteria and Clostridioid Difficile Toxigenic in Residents and Healthcare Workers in Nursing Home (PREMS)
- ClinicalTrials.gov ID
- NCT04579094
- Acronym / sponsor ID
- PREMS / LOCAL/2019/JO-01
- Conditions
- Elderly, Healthcare Associated Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 492 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 8 Oct 2020 (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.
Brief summary : Very few studies have evaluated the prevalence of multi-drug resistant (MDR), highly resistant emerging bacteria and Clostridioides difficile toxinogenic (CDt) in residents and in healthcare workers (HCW) in nursing home (NH). Most of study were conducted in acute care services and were limited to specific bacterial species.
Hypothesis : The carriage of MDR bacteria in resident may be a risk factor for an outbreak in NH or in healthcare facility.
Primary outcome: The objective of this study is to estimate the prevalence for carriage of MDR bacteria and CDt in residents in NH.
Secondary outcomes:
- Estimate the prevalence for carriage of MDR bacteria and CDt toxigenic in HCW in NH.
- Identify the risk factors for carriage of MDR bacteria and CDt in residents in nursing home
- Identify the risk factors for carriage of MDR bacteria and CDt in healthcare workers in NH
- Evaluate the presence of cross-transmission of MDR bacteria and CDt in one or several NH
- Evaluate the association between the presence of cross-transmission of MDR bacteria and CDt in a NH and the management of infection control
- Establishment a collection of stool samples
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/elderly dependent persons | – | Other: Feces sampling at inclusion (J0) |
| 2/healthcare workers (HCW) | – | Other: Feces sampling at inclusion (J0) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population of the study is all elderly residents of nursing home and their caregivers. The source population of the study corresponds to the residents of the 61 nursing home in the Gard region, and their caregivers.
Key inclusion criteria (3 listed)
- Resident :
- The resident must be a member or beneficiary of a health insurance. The resident is in permanent accommodation whose the date of admission is at least 1 month earlier on the day of collection.
- healthcare workers : The healthcare workers must be a member or beneficiary of a health insurance. The healthcare workers begin to work in nursing at least 1 month earlier on the day of collection.
Key exclusion criteria (3 listed)
- Resident :
- The resident refuses to participate.
- o healthcare workers : The healthcare workers refuses to participate.
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 |
|---|---|---|
| Feces sampling at inclusion (J0)Feces sampling at inclusion (J0) | Other | 1/elderly dependent persons, 2/healthcare workers (HCW) |
Primary outcome
Presence or absence of multi-drug resistant bacteria in residents' feces.
Time frame: at inclusion (J0)
prevalence of carriage of multi-drug resistant bacteria
Presence or absence of Highly Resistant and Emerging Bacteria in residents' feces.
Time frame: at inclusion (J0)
prevalence of carriage of Highly Resistant and Emerging Bacteria
Presence or absence of Clostridioids difficult toxinogenic in residents' feces.
Time frame: at inclusion (J0)
prevalence of carriage of Clostridioids difficult toxinogenic
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 28 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Elderly and Healthcare Associated Infection, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 3 inclusion and 3 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 28 May 2025. 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 France. 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?
Presence or absence of multi-drug resistant bacteria in residents' feces. (time frame: at inclusion (J0)). The study lists 3 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 28 May 2025.