Antibiotherapy During Therapeutic Hypothermia to Prevent Infectious Complications
Information source: University Hospital, Limoges
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ventilator-associated Pneumonia; Cardiac Arrests With Shockable Rhythm; Mild Therapeutic Hypothermia; Preventive Antibiotics
Intervention: Amoxicillin - clavulanic acid (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University Hospital, Limoges Official(s) and/or principal investigator(s): Bruno FRANCOIS, MD, Principal Investigator, Affiliation: Limoges UH
Overall contact: Bruno FRANCOIS, MD, Phone: 05 55 05 62 54, Email: realim@unilim.fr
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 arrests, mild therapeutic hypothermia side effects are conductive
for infectious complications and especially for ventilator-associated pneumonia (VAP).
Despite high incidence of VAP and other infectious complications, it is not currently
recommended to use antibiotic prophylaxis on the responsible germs. Yet VAP incidence could
be decreased if an antibiotic therapy was systematically given to patient treated with mild
therapeutic hypothermia after a cardiac arrest. Several retrospective studies showed less
infectious complications but also decreased morbidity and mortality related to these
complications when antibiotic therapy was given early to patients treated with therapeutic
hypothermia after cardiac arrest.
Clinical Details
Official title: Prevention of Early Ventilator-associated Pneumonia With Antibiotic Therapy in Patients Treated With Mild Therapeutic Hypothermia After Cardiac Arrest.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Incidence reduction of early VAP
Secondary outcome: MortalityEarly nosocomial infectious complications
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-hospital cardiac arrest receiving mild therapeutic hypothermia, in addition
to usual VAP prevention measures.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Bruno FRANCOIS, MD, Phone: 05 55 05 62 54, Email: realim@unilim.fr
CH Argenteuil - Service de Réanimation, Argenteuil 95107, France; Not yet recruiting Gaëtan PLANTEFEVE, MD, Phone: 01 34 23 24 51 Gaëtan PLANTEFEVE, MD, Principal Investigator
CH Brive La Gaillarde - Service de Réanimation, Brive La Gaillarde 19100, France; Not yet recruiting Elias KARAM, MD, Phone: 05 55 92 60 13 Elias KARAM, MD, Principal Investigator
CHU Dijon - Serve de Réanimation, Dijon 21079, France; Not yet recruiting Jean-Pierre QUENOT, MD, Phone: 03 80 29 37 51 Jean-Pierre QUENOT, MD, Principal Investigator
AP-HP - Hôpital pointcaré - Service de Réanimation, Garches 92380, France; Not yet recruiting Djillali ANNANE, MD, Phone: 01 47 10 77 80 Djillali ANNANE, MD, Principal Investigator
CHU de Limoges - Service de réanimation polyvalente, Limoges 87042, France; Recruiting Bruno FRANCOIS, MD, Phone: 05 55 05 62 54, Email: b.francois@unilim.fr Thomas DAIX, MD, Phone: 05 55 05 62 54, Email: thomas.daix@wanadoo.fr Bruno FRANCOIS, MD, Principal Investigator
HCL - Hôpital Herriot - service de Réanimation, Lyon 69437, France; Not yet recruiting Laurent ARGAUD, MD, Phone: 04 72 11 00 15 Laurent ARGAUD, MD, Principal Investigator
CH Montauban - service de Réanimation, Montauban 83013, France; Not yet recruiting Frédéric BELLEC, MD, Phone: 05 63 92 81 47 Frédéric BELLEC, MD, Principal Investigator
CHU Orléans - service de Réanimation, Orleans 47067, France; Not yet recruiting Thierry BOULAIN, MD, Phone: 02 38 51 44 46 Thierry BOULAIN, MD, Principal Investigator
AP-HP - Hôpital Cochin - Service de Réanimation, Paris 75014, France; Not yet recruiting Alain CARIOU, MD, Phone: 01 58 41 25 10 Alain CARIOU, MD, Principal Investigator
AP-HP - Hôpital Lariboisière - Service de Réanimation, Paris 75010, France; Not yet recruiting Nicolas DEYE, MD, Phone: 01 49 95 63 47 Nicolas DEYE, MD, Principal Investigator
CH Périgueux, Perigueux 24019, France; Not yet recruiting Loïc CHIMOT, MD, Phone: 05 53 45 25 25 Loïc CHIMOT, MD, Principal Investigator
CHU Strasbourg - service de Réanimation, Strasbourg 67000, France; Not yet recruiting Ferhat MEZIANI, MD, Phone: 03 69 55 04 34 Ferhat MEZIANI, MD, Principal Investigator
CHU Tours - Service de Réanimation, Tours 37044, France; Not yet recruiting Pierre-François DEQUIN, MD, Phone: 02 47 47 38 55 Pierre-François DEQUIN, MD, Principal Investigator
CH Versailles - service de Réanimation, Versailles 78000, France; Not yet recruiting Stéphane LEGRIEL, MD, Phone: 01 39 63 88 39 Stéphane LEGRIEL, MD, Principal Investigator
CH Angouleme - Service de Réanimation, Angoulême, Saint michel 16470, France; Not yet recruiting Arnaud DESACHY, MD, Phone: 05 45 24 41 57 Arnaud DESACHY, MD, Principal Investigator
Additional Information
Starting date: July 2014
Last updated: July 9, 2014
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