Antibiotherapy During Therapeutic Hypothermia to Prevent Infectious Complications

Last updated: March 16, 2020
Sponsor: University Hospital, Limoges
Overall Status: Completed

Phase

3

Condition

Pneumonia

Treatment

N/A

Clinical Study ID

NCT02186951
I13018 ANTHARTIC
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Older than 18 years-old, intubated and mechanically ventilated after out-of-hospitalresuscitated 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

Exclusion Criteria:

  • Pregnancy

  • Out-of-hospital cardiac arrest secondary to non shockable rhythm and In-hospitalcardiac 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 theexcipients.

  • History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to anotherbeta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).

  • History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid, accordingto 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

Study Design

Total Participants: 197
Study Start date:
August 18, 2014
Estimated Completion Date:
September 14, 2017

Study 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.

Connect with a study center

  • CH Angouleme - Service de Réanimation

    Angoulême, Saint Michel 16470
    France

    Site Not Available

  • CH Argenteuil - Service de Réanimation

    Argenteuil, 95107
    France

    Site Not Available

  • CH Brive La Gaillarde - Service de Réanimation

    Brive La Gaillarde, 19100
    France

    Site Not Available

  • CHU Dijon - Serve de Réanimation

    Dijon, 21079
    France

    Site Not Available

  • AP-HP - Hôpital pointcaré - Service de Réanimation

    Garches, 92380
    France

    Site Not Available

  • CH du MANS

    Le Mans, 72000
    France

    Site Not Available

  • CHU de Limoges - Service de réanimation polyvalente

    Limoges, 87042
    France

    Site Not Available

  • HCL - Hôpital Herriot - service de Réanimation

    Lyon, 69437
    France

    Site Not Available

  • CH Montauban - service de Réanimation

    Montauban, 83013
    France

    Site Not Available

  • CHU Nantes - Service de réanimation

    Nantes,
    France

    Site Not Available

  • CHU Orléans - service de Réanimation

    Orleans, 47067
    France

    Site Not Available

  • AP-HP - Hôpital Cochin - Service de Réanimation

    Paris, 75014
    France

    Site Not Available

  • AP-HP - Hôpital Européen Georges Pompidou - Service de Réanimation

    Paris, 75015
    France

    Site Not Available

  • AP-HP - Hôpital Lariboisière - Service de Réanimation

    Paris, 75010
    France

    Site Not Available

  • CH Périgueux

    Perigueux, 24019
    France

    Site Not Available

  • CHU Strasbourg - service de Réanimation

    Strasbourg, 67000
    France

    Site Not Available

  • CHU Tours - Service de Réanimation

    Tours, 37044
    France

    Site Not Available

  • CH Versailles - service de Réanimation

    Versailles, 78000
    France

    Site Not Available

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