Infection, HospitalGer-SPNCT05475574
Impact of Discontinuing Contact Precautions for Extended-spectrum β-lactamase Enterobacteriaceae in a Geriatric Unit
A study testing Discontinuation of contact precautions for ESBLE in people with Infection, Hospital, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
This is an interventional multicenter prospective noninferiority non-randomized double-blind controlled before and after study. The aim of this study is to demonstrate that standard precautions alone are not inferior to contact precautions by comparing the incidence density of extended-spectrum β-lactamase… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Infection, Hospital
- What is being tested?
- Discontinuation of contact precautions for ESBLE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 954 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2023to 21 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adult patient (> 65 years old)
- Patient hospitalized in geriatrics during the study period
- Free and informed consent obtained from the patient (or his trusted person or legal representative) within 48 hours of its admission at the geriatric unit
- Patient affiliated to a social security scheme
- Non Inclusion Criteria:
- Patient requiring contact precaution for an indication other than ESBLE (COVID-19, classical PCC excluding EBLSE, Clostridium difficile PCC, scabies PCC and BHRe PCC) on admission
- Patient under legal protection
- Person deprived of liberty
Who cannot join
- Patient requiring contact precaution for an indication other than ESBL during the patient stay (COVID-19, classical PCC excluding EBLSE, Clostridium difficile PCC, scabies PCC and BHRe PCC)
- Patient's stay period less than 4 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHR Metz-Thionville/Hôpital Bel Air
Metz, 57085
Azzedine AZZEMOU, MD, a.azzemou@chr-metz-thionville.fr
About this study
Official title: Impact of Discontinuing Contact Precautions for Extended-spectrum β-lactamase Enterobacteriaceae (ESBLE) in a Geriatric Unit: an Interventional Prospective Noninferiority Non-randomized Double-blind Controlled Before and After Study
This is an interventional multicenter prospective noninferiority non-randomized double-blind controlled before and after study.
The aim of this study is to demonstrate that standard precautions alone are not inferior to contact precautions by comparing the incidence density of extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae acquired in geriatric units before and after discontinuing contact precautions.
Read the detailed description
Healthcare-associated infections (HAIs) are one of the main causes of morbidity and mortality worldwide. Extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae have become microorganisms frequently found in HAIs, which reduces the therapeutic possibilities.
- Conditions
- Infection, Hospital
- Being tested
- Discontinuation of contact precautions for ESBLE
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation of contact precautions for ESBLEOther
Discontinuation of contact precaution : only standard precaution are implemented for any patient carrying (infected or colonized) ESBLE
| Study group | Role | What they receive |
|---|---|---|
| Before discontinuation of contact precautions for ESBLE | No intervention | Implementation of contact precaution in addition to standard precaution for any patient carrying (infected or colonized) ESBLE |
| After discontinuation of contact precautions for ESBLE | Experimental | Discontinuation of contact precaution : only standard precaution are implemented for any patient carrying (infected or colonized) ESBLE Receives: Other: Discontinuation of contact precautions for ESBLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence density of acquired ESBLE
Incidence density of acquired ESBLE in geriatric unit for 1000 days of hospitalization is calculated by dividing the number of acquired ESBLE by the number of days of patients' hospitalization multiplied by 1000 Acquisition of ESBLE is defined by a positive sample in patient on discharge day with a negative sample on admission in geriatric unit A positive sample is defined by the presence of at least one ESBLE on a clinical (infection) or screening (colonization) sample.
The hospitalisation number is calculated as the cumulative length of stay of all patients at risk (= negative on admission).
Measured: during 6 month period
Secondary outcomes (5)
Incidence density of acquired ESBLE by species during 6 month period
Incidence density of acquired ESBLE in geriatric unit by species (E. coli versus non-E. coli) for 1000 days of hospitalization. This is calculated by dividing the number of acquired ESBLE by species by the number of days of patients' hospitalization multiplied by 1000.
Acquisition of ESBLE is defined by a positive sample in patient on discharge day with a negative sample on admission in geriatric unit A positive sample is defined by the presence of at least one ESBLE on a clinical (infection) or screening (colonization) sample.
The hospitalisation number is calculated as the cumulative length of stay of all patients at risk (= negative on admission).
Measured: during 6 month period
The rate of compliance with hand hygiene in health care providers
The evaluation of the compliance with hygiene measures is calculated in health care providers by dividing the number of hand hygiene moments carried out by the number of opportunities multiplied by 100, according to the World Health Organization (WHO) methodology
Measured: Up to 3 months per health department
Evaluation of the barriers to alcohol-based hand rub in case of non-compliance in health care providers
The barriers to alcohol-based hand rub are identified in case of non-compliance, using a Pulpe' friction questionnaire (RéPIAS) where professionals are interviewed about their practices in terms of hand hygiene. For each situation, the professional is also asked how important it is for him to perform hand hygiene in each situation listed above, with a slider to be positioned between 0 (not at all important; worse outcome) and 10 (the most important; better outcome).
Measured: Up to 3 months per health department
The rate of compliance with personal protective equipment
The rate of compliance with the wearing and removal of personal protective equipment throughout patient care, is observed during care related to the management of excreta (changing, putting on or removing a dish basin, use of a basin washer-disinfector).
The rate is calculated by dividing the number of personal protective equipment good caring practices by the number of opportunities multiplied by 100.
Measured: Up to 3 months per health department
Evaluation of satisfaction related to patient care, by self-questionnaire Hospital anxiety and depression scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score.
Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case.
Measured: on the day of discharge of the geriatric unit, on average on the 11th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start7 Mar 2023
- Primary completion7 Sep 2029 (estimated)
- Study completion21 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, HospitalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 954 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noel BLETTNER, MD, Principal investigator, Mercy Hospital CHR Metz ThionvilleAzzeddine AZZEMOU, MD, Principal investigator, Bel Air Hospital CHR Metz Thionville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475574
- Sponsor's protocol ID
- 2021-05-CHRMT
- Acronym
- Ger-SP
- Status last verified
- Jun 2026
- First submitted
- 13 Jul 2022
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Discontinuing Contact Precautions for Extended-spectrum β-lactamase Enterobacteriaceae (ESBLE) in a Geriatric Unit: an Interventional Prospective Noninferiority Non-randomized Double-blind Controlled Before and After Study
- ClinicalTrials.gov ID
- NCT05475574
- Acronym / sponsor ID
- Ger-SP / 2021-05-CHRMT
- Conditions
- Infection, Hospital
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 954 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 7 Sep 2029 (estimated)
- Study completion
- 21 Sep 2029 (estimated)
- First posted
- 27 Jul 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.
This is an interventional multicenter prospective noninferiority non-randomized double-blind controlled before and after study.
The aim of this study is to demonstrate that standard precautions alone are not inferior to contact precautions by comparing the incidence density of extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae acquired in geriatric units before and after discontinuing contact precautions.
Detailed description
Healthcare-associated infections (HAIs) are one of the main causes of morbidity and mortality worldwide. Extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae have become microorganisms frequently found in HAIs, which reduces the therapeutic possibilities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before discontinuation of contact precautions for ESBLE | No intervention | –Implementation of contact precaution in addition to standard precaution for any patient carrying (infected or colonized) ESBLE |
| After discontinuation of contact precautions for ESBLE | Experimental | Other: Discontinuation of contact precautions for ESBLEDiscontinuation of contact precaution : only standard precaution are implemented for any patient carrying (infected or colonized) ESBLE |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Adult patient (> 65 years old)
- Patient hospitalized in geriatrics during the study period
- Free and informed consent obtained from the patient (or his trusted person or legal representative) within 48 hours of its admission at the geriatric unit
- Patient affiliated to a social security scheme
- Patient requiring contact precaution for an indication other than ESBLE (COVID-19, classical PCC excluding EBLSE, Clostridium difficile PCC, scabies PCC and BHRe PCC) on admission
Key exclusion criteria (2 listed)
- Patient requiring contact precaution for an indication other than ESBL during the patient stay (COVID-19, classical PCC excluding EBLSE, Clostridium difficile PCC, scabies PCC and BHRe PCC)
- Patient's stay period less than 4 days
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 |
|---|---|---|
| Discontinuation of contact precautions for ESBLEDiscontinuation of contact precaution : only standard precaution are implemented for any patient carrying (infected or colonized) ESBLE | Other | After discontinuation of contact precautions for ESBLE |
Primary outcome
Incidence density of acquired ESBLE
Time frame: during 6 month period
Incidence density of acquired ESBLE in geriatric unit for 1000 days of hospitalization is calculated by dividing the number of acquired ESBLE by the number of days of patients' hospitalization multiplied by 1000 Acquisition of ESBLE is defined by a positive sample in patient on discharge day with a negative sample on admission in geriatric unit A positive sample is defined by the presence of at least one ESBLE on a clinical (infection) or screening (colonization) sample. The hospitalisation number is calculated as the cumulative length of stay of all patients at risk (= negative on admission).
5 secondary outcomes
Incidence density of acquired ESBLE by species during 6 month period
Time frame: during 6 month period
The rate of compliance with hand hygiene in health care providers
Time frame: Up to 3 months per health department
Evaluation of the barriers to alcohol-based hand rub in case of non-compliance in health care providers
Time frame: Up to 3 months per health department
The rate of compliance with personal protective equipment
Time frame: Up to 3 months per health department
Evaluation of satisfaction related to patient care, by self-questionnaire Hospital anxiety and depression scale (HADS)
Time frame: on the day of discharge of the geriatric unit, on average on the 11th day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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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.
Noel BLETTNER, MD principal investigator
Mercy Hospital CHR Metz Thionville
Azzeddine AZZEMOU, MD principal investigator
Bel Air Hospital CHR Metz Thionville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discontinuation of contact precautions for ESBLE in people with Infection, Hospital, run by Centre Hospitalier Régional Metz-Thionville 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 8 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 24 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurie RENAUDIN, MD (03 87 55 30 25 ext. 0033, l.renaudin@chr-metz-thionville.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence density of acquired ESBLE (time frame: during 6 month period). 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 24 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.