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Antibiotherapy During Therapeutic Hypothermia to Prevent Infectious Complications (ANTHARTIC)

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ClinicalTrials.gov Identifier: NCT02186951
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Study Description
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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 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.


Condition or disease Intervention/treatment Phase
Ventilator-associated Pneumonia Cardiac Arrests With Shockable Rhythm Mild Therapeutic Hypothermia Preventive Antibiotics Drug: Amoxicillin - clavulanic acid Drug: Placebo Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prevention of Early Ventilator-associated Pneumonia With Antibiotic Therapy in Patients Treated With Mild Therapeutic Hypothermia After Cardiac Arrest.
Actual Study Start Date : August 18, 2014
Actual Primary Completion Date : October 27, 2016
Actual Study Completion Date : September 14, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Amoxicillin clavulanic acid
Amoxicillin-clavulanic acid 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia.
 Drug: Amoxicillin - clavulanic acid
Amoxicillin-clavulanic acid 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia.
Placebo Comparator: Placebo
Placebo 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia.
 Drug: Placebo
Placebo 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence reduction of early VAP [ Time Frame: 7 days ]
    Incidence reduction of early VAP with short term amoxicillin-clavulanic acid in patients treated with hypothermia after out-of-hospital cardiac arrest


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 28 days ]
    Mortality

  2. Early nosocomial infectious complications [ Time Frame: 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186951


Locations
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France
CH Angouleme - Service de Réanimation
Angoulême, Saint Michel, France, 16470
CH Argenteuil - Service de Réanimation
Argenteuil, France, 95107
CH Brive La Gaillarde - Service de Réanimation
Brive La Gaillarde, France, 19100
CHU Dijon - Serve de Réanimation
Dijon, France, 21079
AP-HP - Hôpital pointcaré - Service de Réanimation
Garches, France, 92380
CH du MANS
Le Mans, France, 72000
CHU de Limoges - Service de réanimation polyvalente
Limoges, France, 87042
CHU Nantes - Service de réanimation
Nantes, France
CHU Orléans - service de Réanimation
Orleans, France, 47067
AP-HP - Hôpital Lariboisière - Service de Réanimation
Paris, France, 75010
AP-HP - Hôpital Cochin - Service de Réanimation
Paris, France, 75014
AP-HP - Hôpital Européen Georges Pompidou - Service de Réanimation
Paris, France, 75015
CH Périgueux
Perigueux, France, 24019
CHU Strasbourg - service de Réanimation
Strasbourg, France, 67000
CHU Tours - Service de Réanimation
Tours, France, 37044
CH Versailles - service de Réanimation
Versailles, France, 78000
Sponsors and Collaborators
University Hospital, Limoges
Investigators
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Principal Investigator: Bruno FRANCOIS, MD Limoges UH
More Information
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02186951     History of Changes
Other Study ID Numbers: I13018 ANTHARTIC
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Keywords provided by University Hospital, Limoges:
ventilator-associated pneumonia
cardiac arrests with shockable rhythm
Mild therapeutic hypothermia
preventive antibiotics
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Heart Arrest
Hypothermia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms
 Cross Infection
Infection
Amoxicillin
Clavulanic Acids
Clavulanic Acid
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors