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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT02186951
Eligibility Criteria:
Inclusion Criteria:
* Older than 18 years-old, intubated and mechanically ventilated after out-of-hospital resuscitated cardiac arrest secondary to shockable rhythm
* Hospitalized in an ICU
* Mild therapeutic hypothermia procedure (32° to 35°C) scheduled (24 to 36 hours)
* Delay from ROSC to randomisation \< 6 hours
* Consent from family members or emergency consent
Exclusion Criteria:
* Pregnancy
* Out-of-hospital cardiac arrest secondary to non shockable rhythm and In-hospital cardiac arrest
* Need for cardiac support by cardiopulmonary bypass
* Ongoing antibiotic therapy or during the week before
* Ongoing or concomitant pneumonia
* Known chronic colonization with MRB
* Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients.
* History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).
* History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid, according to the latest version of the SmPC.
* Previous lung disease
* Predictable decision of early care limitation
* Patient under guardianship or curatorship
* Moribund patient
* Participation to another trial within 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02186951
Study Brief:
Protocol Section:
NCT02186951