Impact of Discontinuing Contact Precautions for Extended-spectrum β-lactamase Enterobacteriaceae in a Geriatric Unit

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCentre Hospitalier Régional Metz-Thionville

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Crossover

Treatments tested in this trial

  • Discontinuation of contact precautions for ESBLE

    Other intervention

    Discontinuation of contact precaution : only standard precaution are implemented for any patient carrying (infected or colonized) ESBLE

Treatment groups

954 Participants
are divided into 2 treatment groups
Group A: Before discontinuation of contact precautions for ESBLENo intervention 0 interventions
Group B: After discontinuation of contact precautions for ESBLEExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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