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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT04825132
Eligibility Criteria:
Inclusion Criteria For Case:
* Hospitalized adults 65 years or older,
* Presenting with bacteremia with positive blood culture (excluding catheter related infections) and/or
* WHO Severe Acute Respiratory Infection (SARI) case definition
* Upper respiratory infection = SARI (fever or history of fever \>38°C, cough, onset of the disease within the last 10 days and requires hospitalisation)
* Lower respiratory infection = SARI with confirmed CT/CHR
* Informed consent form signed
* Patient affiliated to social security insurance
Exclusion Criteria For Case:
* Bedridden or terminally ill patient (based upon a threshold of ADL: ≤2 TBD, or CLINICAL FRAILTY SCALE: ≥8 )
* Patients that refuse the 3- and 6-months follow-up phone call assessments
* Patients that will not be able to answer the 3- and 6-months follow-up phone call assessments via a nurse
* Subject in exclusion period for another study,
* Subject who cannot be contacted in an emergency
* Persons referred to in Articles L1121-5 to L1121-8 of the French code of public health (this corresponds to all persons protected: pregnant or parturient women, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure).
Inclusion Criteria For Controls
* Same age (+/- 3 years)
* same sex,
* without suspicion of infection
* Hospitalized during the past or upcoming month in the same centre.
* Informed consent form signed
* Patient affiliated to social security insurance
Exclusion Criteria For Controls
* Bedridden or terminally ill patient (based upon a threshold of ADL: ≤2 TBD, or CLINICAL FRAILTY SCALE: ≥8 )
* Patients that refuse the 3- and 6-months follow-up phone call assessments
* Patients that will not be able to answer the 3- and 6-months follow-up phone call assessments via a nurse
* Subject in exclusion period for another study,
* Subject who cannot be contacted in an emergency
* Persons referred to in Articles L1121-5 to L1121-8 of the French code of public health (this corresponds to all persons protected: pregnant or parturient women, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04825132
Study Brief:
Protocol Section:
NCT04825132