Antibiotherapy During Therapeutic Hypothermia to Prevent Infectious Complications (ANTHARTIC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02186951 |
Recruitment Status :
Completed
First Posted : July 10, 2014
Last Update Posted : March 18, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |

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. |
- 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
- Mortality [ Time Frame: 28 days ]Mortality
- Early nosocomial infectious complications [ Time Frame: 28 days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Principal Investigator: | Bruno FRANCOIS, MD | Limoges UH |
Responsible Party: | University Hospital, Limoges |
ClinicalTrials.gov Identifier: | NCT02186951 |
Other Study ID Numbers: |
I13018 ANTHARTIC |
First Posted: | July 10, 2014 Key Record Dates |
Last Update Posted: | March 18, 2020 |
Last Verified: | March 2020 |
ventilator-associated pneumonia cardiac arrests with shockable rhythm Mild therapeutic hypothermia preventive antibiotics |
Pneumonia Pneumonia, Ventilator-Associated Heart Arrest Hypothermia Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases Heart Diseases Cardiovascular Diseases Body Temperature Changes Healthcare-Associated Pneumonia |
Cross Infection Iatrogenic Disease Disease Attributes Pathologic Processes Amoxicillin Clavulanic Acids Clavulanic Acid Anti-Bacterial Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action beta-Lactamase Inhibitors |