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NCT Number: NCT05475574

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

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.

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Key information

Conditions

Infection, Hospital Cross Infection Disease Attributes Iatrogenic Disease Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR Metz-Thionville/Hôpital Bel Air

Metz, 57085, France

Location status: Recruiting

Location contact

Azzedine AZZEMOU, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Discontinuation of contact precautions for ESBLE

Other

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Incidence density of acquired ESBLE by species during 6 month period

    Time frame: 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).

  2. The rate of compliance with hand hygiene in health care providers

    Time frame: 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

  3. 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 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).

  4. The rate of compliance with personal protective equipment

    Time frame: 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.

  5. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laurie RENAUDIN, MD

CONTACT

[email protected]

03 87 55 30 25 ext. 0033

Mathieu LLORENS, MD

CONTACT

[email protected]

03 87 55 38 39 ext. 0033

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study 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

Acronym: Ger-SP

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Jul 27, 2022
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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