Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-20 @ 9:00 AM
Study NCT ID:
NCT02186951
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2014-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotherapy During Therapeutic Hypothermia to Prevent Infectious Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019980', 'term': 'Amoxicillin-Potassium Clavulanate Combination'}], 'ancestors': [{'id': 'D019818', 'term': 'Clavulanic Acid'}, {'id': 'D002969', 'term': 'Clavulanic Acids'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 197}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2014-07-08', 'studyFirstSubmitQcDate': '2014-07-09', 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence reduction of early VAP', 'timeFrame': '7 days', 'description': 'Incidence reduction of early VAP with short term amoxicillin-clavulanic acid in patients treated with hypothermia after out-of-hospital cardiac arrest'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '28 days', 'description': 'Mortality'}, {'measure': 'Early nosocomial infectious complications', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ventilator-associated pneumonia', 'cardiac arrests with shockable rhythm', 'Mild therapeutic hypothermia', 'preventive antibiotics'], 'conditions': ['Ventilator-associated Pneumonia', 'Cardiac Arrests With Shockable Rhythm', 'Mild Therapeutic Hypothermia', 'Preventive Antibiotics']}, 'referencesModule': {'references': [{'pmid': '31693806', 'type': 'RESULT', 'citation': 'Francois B, Cariou A, Clere-Jehl R, Dequin PF, Renon-Carron F, Daix T, Guitton C, Deye N, Legriel S, Plantefeve G, Quenot JP, Desachy A, Kamel T, Bedon-Carte S, Diehl JL, Chudeau N, Karam E, Durand-Zaleski I, Giraudeau B, Vignon P, Le Gouge A; CRICS-TRIGGERSEP Network and the ANTHARTIC Study Group. Prevention of Early Ventilator-Associated Pneumonia after Cardiac Arrest. N Engl J Med. 2019 Nov 7;381(19):1831-1842. doi: 10.1056/NEJMoa1812379.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nDespite 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years-old, intubated and mechanically ventilated after out-of-hospital resuscitated cardiac arrest secondary to shockable rhythm\n* Hospitalized in an ICU\n* Mild therapeutic hypothermia procedure (32° to 35°C) scheduled (24 to 36 hours)\n* Delay from ROSC to randomisation \\< 6 hours\n* Consent from family members or emergency consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Out-of-hospital cardiac arrest secondary to non shockable rhythm and In-hospital cardiac arrest\n* Need for cardiac support by cardiopulmonary bypass\n* Ongoing antibiotic therapy or during the week before\n* Ongoing or concomitant pneumonia\n* Known chronic colonization with MRB\n* Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients.\n* History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).\n* History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid, according to the latest version of the SmPC.\n* Previous lung disease\n* Predictable decision of early care limitation\n* Patient under guardianship or curatorship\n* Moribund patient\n* Participation to another trial within 30 days'}, 'identificationModule': {'nctId': 'NCT02186951', 'acronym': 'ANTHARTIC', 'briefTitle': 'Antibiotherapy During Therapeutic Hypothermia to Prevent Infectious Complications', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Prevention of Early Ventilator-associated Pneumonia With Antibiotic Therapy in Patients Treated With Mild Therapeutic Hypothermia After Cardiac Arrest.', 'orgStudyIdInfo': {'id': 'I13018 ANTHARTIC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amoxicillin clavulanic acid', 'description': 'Amoxicillin-clavulanic acid 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia.', 'interventionNames': ['Drug: Amoxicillin - clavulanic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Amoxicillin - clavulanic acid', 'type': 'DRUG', 'description': 'Amoxicillin-clavulanic acid 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia.', 'armGroupLabels': ['Amoxicillin clavulanic acid']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16470', 'city': 'Angoulême', 'state': 'Saint Michel', 'country': 'France', 'facility': 'CH Angouleme - Service de Réanimation', 'geoPoint': {'lat': 45.64997, 'lon': 0.15345}}, {'zip': '95107', 'city': 'Argenteuil', 'country': 'France', 'facility': 'CH Argenteuil - Service de Réanimation', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '19100', 'city': 'Brive-la-Gaillarde', 'country': 'France', 'facility': 'CH Brive La Gaillarde - Service de Réanimation', 'geoPoint': {'lat': 45.1589, 'lon': 1.53326}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon - Serve de Réanimation', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'AP-HP - Hôpital pointcaré - Service de Réanimation', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'zip': '72000', 'city': 'Le Mans', 'country': 'France', 'facility': 'CH du MANS', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'CHU de Limoges - Service de réanimation polyvalente', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CHU Nantes - Service de réanimation', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '47067', 'city': 'Orléans', 'country': 'France', 'facility': 'CHU Orléans - service de Réanimation', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP - Hôpital Lariboisière - Service de Réanimation', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP - Hôpital Cochin - Service de Réanimation', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP - Hôpital Européen Georges Pompidou - Service de Réanimation', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '24019', 'city': 'Périgueux', 'country': 'France', 'facility': 'CH Périgueux', 'geoPoint': {'lat': 45.18691, 'lon': 0.71439}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'CHU Strasbourg - service de Réanimation', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHU Tours - Service de Réanimation', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '78000', 'city': 'Versailles', 'country': 'France', 'facility': 'CH Versailles - service de Réanimation', 'geoPoint': {'lat': 48.80359, 'lon': 2.13424}}], 'overallOfficials': [{'name': 'Bruno FRANCOIS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Limoges UH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}