Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT07159568
Eligibility Criteria:
Inclusion Criteria:
* Adult patient aged 18 years or older,
* Admitted to one of the participating ICUs at Clermont-Ferrand University Hospital (Estaing Adult ICU, Montpied Medical-Surgical ICU, or Montpied Neuro-ICU) with an expected ICU stay of 48 hours or more,
* Owner of a companion dog, with family members or relatives able to bring the dog to the ICU.
Exclusion Criteria:
Patient-related exclusion criteria:
* Refusal by the patient or by their family/relatives to participate,
* Lack of affiliation with the French national health insurance system (Sécurité Sociale),
* Patient deprived of liberty or under legal protection (guardianship, curatorship, or judicial safeguard),
* Pregnant or breastfeeding patient,
* Agitated patient, defined as a Richmond Agitation-Sedation Scale (RASS) score \> 0 (monitored every four hours according to current standard practice),
* Patient with immunosuppression, defined as: blood neutrophil count \< 0.5 G/L, ongoing or recent (within the past month) treatment for solid or hematologic cancer (e.g., chemotherapy, radiotherapy, cell therapy), or receiving immunosuppressive drugs (including organ transplant recipients or corticosteroid therapy for more than two weeks),
* Patient with known colonization by multidrug-resistant bacteria (as routinely assessed upon ICU admission and weekly thereafter),
* Patient with one or more open wounds or injuries that cannot be covered with a dressing.
Dog-related exclusion criteria:
* Dog belonging to category 1 or 2 breeds considered dangerous under current French regulations,
* Dog that never leaves the home environment,
* Dog with an incomplete vaccination status,
* Dog with a known transmissible disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07159568
Study Brief:
Protocol Section:
NCT07159568