Evaluating the effects of stopping contact precautions for certain infections in elderly patients
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
NA · Centre Hospitalier Régional Metz-Thionville · NCT05475574
This study is testing if using standard safety measures instead of stricter contact precautions can still keep elderly patients safe from certain infections while they are in the hospital.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 954 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Régional Metz-Thionville (other) |
| Locations | 1 site (Metz) |
| Trial ID | NCT05475574 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to assess whether standard precautions alone are as effective as contact precautions in preventing the spread of extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae in geriatric units. It is a multicenter, prospective, noninferiority, non-randomized, double-blind controlled study that compares the incidence of infections before and after the discontinuation of contact precautions. The study will involve adult patients over 65 years old who are hospitalized in geriatrics and will require informed consent. The goal is to determine if the change in precaution protocols can maintain patient safety while potentially reducing unnecessary restrictions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 65 years old who are hospitalized in geriatric units and can provide informed consent.
Not a fit: Patients requiring contact precautions for other infections or those under legal protection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more efficient infection control practices in geriatric units, improving patient comfort and resource allocation.
How similar studies have performed: While there have been studies on infection control practices, this specific approach to discontinuing contact precautions for ESBL-producing bacteria in geriatric units is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Metz
- CHR Metz-Thionville/Hôpital Bel Air — Metz, France (RECRUITING)
Study contacts
- Principal investigator: Noel BLETTNER, MD — Mercy Hospital CHR Metz Thionville
- Study coordinator: Laurie RENAUDIN, MD
- Email: l.renaudin@chr-metz-thionville.fr
- Phone: 03 87 55 30 25
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infection, Hospital