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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amoxicillin clavulanic acid | Experimental | Amoxicillin-clavulanic acid 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia. |
|
| Placebo | Placebo Comparator | Placebo 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin - clavulanic acid | Drug | Amoxicillin-clavulanic acid 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence reduction of early VAP | Incidence reduction of early VAP with short term amoxicillin-clavulanic acid in patients treated with hypothermia after out-of-hospital cardiac arrest | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Mortality | 28 days |
| Early nosocomial infectious complications | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno FRANCOIS, MD | Limoges UH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Angouleme - Service de Réanimation | Angoulême | Saint Michel | 16470 | France | ||
| CH Argenteuil - Service de Réanimation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31693806 | Result | 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. |
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| Placebo | Drug | Placebo 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia. |
|
| Argenteuil |
| 95107 |
| France |
| CH Brive La Gaillarde - Service de Réanimation | Brive-la-Gaillarde | 19100 | France |
| CHU Dijon - Serve de Réanimation | Dijon | 21079 | France |
| AP-HP - Hôpital pointcaré - Service de Réanimation | Garches | 92380 | France |
| CH du MANS | Le Mans | 72000 | France |
| CHU de Limoges - Service de réanimation polyvalente | Limoges | 87042 | France |
| CHU Nantes - Service de réanimation | Nantes | France |
| CHU Orléans - service de Réanimation | Orléans | 47067 | France |
| AP-HP - Hôpital Lariboisière - Service de Réanimation | Paris | 75010 | France |
| AP-HP - Hôpital Cochin - Service de Réanimation | Paris | 75014 | France |
| AP-HP - Hôpital Européen Georges Pompidou - Service de Réanimation | Paris | 75015 | France |
| CH Périgueux | Périgueux | 24019 | France |
| CHU Strasbourg - service de Réanimation | Strasbourg | 67000 | France |
| CHU Tours - Service de Réanimation | Tours | 37044 | France |
| CH Versailles - service de Réanimation | Versailles | 78000 | France |
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| ID | Term |
|---|---|
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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