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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:

Mortality

Early 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

Page last updated: August 20, 2015

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