Infection, Hospital
Conditions
Brief 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 (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.
Interventions
OTHERDiscontinuation of contact precautions for ESBLE
Discontinuation of contact precaution : only standard precaution are implemented for any patient carrying (infected or colonized) ESBLE
Sponsors
Centre Hospitalier Régional Metz-Thionville
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence density of acquired ESBLE | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence density of acquired ESBLE by species during 6 month period | 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). |
| The rate of compliance with hand hygiene in health care providers | Up to 3 months per health department | 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 |
| Evaluation of the barriers to alcohol-based hand rub in case of non-compliance in health care providers | Up to 3 months per health department | 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). |
| The rate of compliance with personal protective equipment | Up to 3 months per health department | 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. |
| Evaluation of satisfaction related to patient care, by self-questionnaire Hospital anxiety and depression scale (HADS) | on the day of discharge of the geriatric unit, on average on the 11th day | 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. |
Countries
France
Contacts
CONTACTLaurie RENAUDIN, MD
CONTACTMathieu LLORENS, MD
PRINCIPAL_INVESTIGATORNoel BLETTNER, MD
Mercy Hospital CHR Metz Thionville
PRINCIPAL_INVESTIGATORAzzeddine AZZEMOU, MD
Bel Air Hospital CHR Metz Thionville
Outcome results
None listed