An interventional study of Discontinuation of contact precautions for ESBLE in Infection, Hospital, sponsored by Centre Hospitalier Régional Metz-Thionville. Recruiting at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Centre Hospitalier Régional Metz-Thionville · Not applicable, Interventional, and Prevention
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.
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.
285 studies on the registry are indexed under Cross Infection; 48 are open to participants now.
This study's planned enrollment of 954 is above the median of 185 across 169 interventional studies indexed under Cross Infection.
Browse Cross Infection studies →Centre Hospitalier Régional Metz-Thionville is the lead sponsor of 123 studies on the registry; 21 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Non Inclusion Criteria:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Implementation of contact precaution in addition to standard precaution for any patient carrying (infected or colonized) ESBLE
Discontinuation of contact precaution : only standard precaution are implemented for any patient carrying (infected or colonized) ESBLE
Other: Discontinuation of contact precautions for ESBLE
Discontinuation of contact precaution : only standard precaution are implemented for any patient carrying (infected or colonized) ESBLE
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).
Time frame: during 6 month period
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).
Time frame: 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
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
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).
Time frame: 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.
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)
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.
Time frame: on the day of discharge of the geriatric unit, on average on the 11th day
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