Status:
COMPLETED
Antibiotherapy During Therapeutic Hypothermia to Prevent Infectious Complications
Lead Sponsor:
University Hospital, Limoges
Conditions:
Ventilator-associated Pneumonia
Cardiac Arrests With Shockable Rhythm
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Mild therapeutic hypothermia is currently recommended in management of cardiac arrests with shockable rhythm. In mechanically ventilated patients who were resuscitated after out-of-hospital cardiac ar...
Detailed Description
Multicenter add-on randomized controlled double-blind trial assessing the efficacy of preventive antibiotics amoxicillin-clavulanic acid vs placebo to prevent occurrence of early VAP after out-of-hosp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 18 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2017
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT02186951
Start Date
August 18 2014
End Date
September 14 2017
Last Update
March 18 2020
Active Locations (16)
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1
CH Angouleme - Service de Réanimation
Angoulême, Saint Michel, France, 16470
2
CH Argenteuil - Service de Réanimation
Argenteuil, France, 95107
3
CH Brive La Gaillarde - Service de Réanimation
Brive-la-Gaillarde, France, 19100
4
CHU Dijon - Serve de Réanimation
Dijon, France, 21079