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Hospital","116",{"type":54,"coordinates":1182},[1175,1176],{"lat":1176,"lon":1175},{"facility":1185,"status":28,"city":1186,"state":1187,"zip":1188,"country":1189,"countryCode":1190,"cosmosGeoPoint":28,"geoPoint":28,"contacts":28},"Faculty of Medicine Siriraj Hospital","Bangkoknoi","Bangkok","10700","Thailand","TH",{"facility":1192,"status":28,"city":1193,"state":1194,"zip":1195,"country":1189,"countryCode":1190,"cosmosGeoPoint":28,"geoPoint":28,"contacts":28},"Srinagarind Hospital, Division of Infectious Disease and Tropical Medicine","Muang","Changwat Khon Kaen","40002",{"facility":1197,"status":28,"city":1193,"state":1198,"zip":1199,"country":1189,"countryCode":1190,"cosmosGeoPoint":28,"geoPoint":28,"contacts":28},"Bamrasnaradura Infectious Disease Institute (BIDI)","Changwat Nonthaburi","11000",{"facility":1201,"status":28,"city":1202,"state":1203,"zip":1204,"country":1189,"countryCode":1190,"cosmosGeoPoint":1205,"geoPoint":1209,"contacts":28},"Songklanagarind Hospital, Prince of Songkla University","Hat Yai","Changwat Songkhla","90110",{"type":54,"coordinates":1206},[1207,1208],100.47668,7.00836,{"lat":1208,"lon":1207},{"facility":1211,"status":28,"city":1212,"state":28,"zip":1213,"country":1214,"countryCode":28,"cosmosGeoPoint":1215,"geoPoint":1219,"contacts":28},"Hacettepe Universitesi Tip Fakultesi","Ankara","06100","Turkey (Türkiye)",{"type":54,"coordinates":1216},[1217,1218],32.85427,39.91987,{"lat":1218,"lon":1217},{"facility":1221,"status":28,"city":1212,"state":28,"zip":1222,"country":1214,"countryCode":28,"cosmosGeoPoint":1223,"geoPoint":1225,"contacts":28},"Ankara University Faculty of Medicine","06230",{"type":54,"coordinates":1224},[1217,1218],{"lat":1218,"lon":1217},{"facility":1227,"status":28,"city":1212,"state":28,"zip":1228,"country":1214,"countryCode":28,"cosmosGeoPoint":1229,"geoPoint":1231,"contacts":28},"T.C. Saglik Bakanligi Ankara Sehir Hastanesi","06800",{"type":54,"coordinates":1230},[1217,1218],{"lat":1218,"lon":1217},{"facility":1233,"status":28,"city":1234,"state":28,"zip":1235,"country":1214,"countryCode":28,"cosmosGeoPoint":1236,"geoPoint":1240,"contacts":28},"Acibadem Atakent Hospital","Istanbul","34303",{"type":54,"coordinates":1237},[1238,1239],28.94966,41.01384,{"lat":1239,"lon":1238},{"facility":1242,"status":28,"city":1234,"state":28,"zip":1243,"country":1214,"countryCode":28,"cosmosGeoPoint":1244,"geoPoint":1246,"contacts":28},"Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi","34899",{"type":54,"coordinates":1245},[1238,1239],{"lat":1239,"lon":1238},{"facility":1248,"status":28,"city":1249,"state":28,"zip":1250,"country":1214,"countryCode":28,"cosmosGeoPoint":1251,"geoPoint":1255,"contacts":28},"Ege University Faculty of Medicine","Izmir","35040",{"type":54,"coordinates":1252},[1253,1254],27.13838,38.41273,{"lat":1254,"lon":1253},{"facility":1257,"status":28,"city":1258,"state":28,"zip":1259,"country":1214,"countryCode":28,"cosmosGeoPoint":1260,"geoPoint":1264,"contacts":28},"Kocaeli University Medical Faculty","Kocaeli","41380",{"type":54,"coordinates":1261},[1262,1263],27.51145,39.62497,{"lat":1263,"lon":1262},{"facility":1266,"status":28,"city":1267,"state":28,"zip":1268,"country":1214,"countryCode":28,"cosmosGeoPoint":1269,"geoPoint":1273,"contacts":28},"Karadeniz Technical University Medical Faculty Farabi Hospital","Trabzon","61080",{"type":54,"coordinates":1270},[1271,1272],39.72694,41.005,{"lat":1272,"lon":1271},{"facility":1275,"status":28,"city":1276,"state":28,"zip":1277,"country":1278,"countryCode":1279,"cosmosGeoPoint":1280,"geoPoint":1284,"contacts":28},"OKU \"Chernivetska oblasna klinichna likarnia\", khirurhichne viddilennia","Chernivtsi","58001","Ukraine","UA",{"type":54,"coordinates":1281},[1282,1283],25.93241,48.29045,{"lat":1283,"lon":1282},{"facility":1286,"status":28,"city":1287,"state":28,"zip":1288,"country":1278,"countryCode":1279,"cosmosGeoPoint":1289,"geoPoint":1293,"contacts":28},"KZ \"Dnipropetrovska oblasna klinichna likarnia im. I.I. Mechnykova\", viddilennia khirurhii №2","Dnipro","49005",{"type":54,"coordinates":1290},[1291,1292],35.04066,48.46664,{"lat":1292,"lon":1291},{"facility":1295,"status":28,"city":1287,"state":28,"zip":1296,"country":1278,"countryCode":1279,"cosmosGeoPoint":1297,"geoPoint":1299,"contacts":28},"Komunalnyi zaklad \"Miska klinichna likarnia No.4\" Dniprovskoi miskoi rady, viddilennia profpatolohii","49102",{"type":54,"coordinates":1298},[1291,1292],{"lat":1292,"lon":1291},{"facility":1301,"status":28,"city":1302,"state":28,"zip":1303,"country":1278,"countryCode":1279,"cosmosGeoPoint":1304,"geoPoint":1308,"contacts":28},"Oblasna klinichna likarnia, viddilennia anesteziolohii ta intensyvnoi terapii","Ivano-Frankivsk","76008",{"type":54,"coordinates":1305},[1306,1307],24.71248,48.92312,{"lat":1307,"lon":1306},{"facility":1310,"status":28,"city":1302,"state":28,"zip":1311,"country":1278,"countryCode":1279,"cosmosGeoPoint":1312,"geoPoint":1314,"contacts":28},"Ivano-Frankivska tsentralna miska klin likarnia, viddilennia khirurhii,","76018",{"type":54,"coordinates":1313},[1306,1307],{"lat":1307,"lon":1306},{"facility":1316,"status":28,"city":1317,"state":28,"zip":1318,"country":1278,"countryCode":1279,"cosmosGeoPoint":1319,"geoPoint":1323,"contacts":28},"DU \"Instytut zahalnoi ta nevidkladnoi khirurhii imeni V.T. Zaitseva Natsionalnoi akademii medychnykh","Kharkiv","61103",{"type":54,"coordinates":1320},[1321,1322],36.25475,49.98177,{"lat":1322,"lon":1321},{"facility":1325,"status":28,"city":1326,"state":28,"zip":1327,"country":1278,"countryCode":1279,"cosmosGeoPoint":1328,"geoPoint":1332,"contacts":28},"Kyivska miska klinichna likarnia No. 3, khirurhichne viddilennia","Kyiv","02125",{"type":54,"coordinates":1329},[1330,1331],30.5238,50.45466,{"lat":1331,"lon":1330},{"facility":1334,"status":28,"city":1326,"state":28,"zip":1335,"country":1278,"countryCode":1279,"cosmosGeoPoint":1336,"geoPoint":1338,"contacts":28},"Kyivska miska klinichna likarnia #4, khirurhichne viddilennia #1","03110",{"type":54,"coordinates":1337},[1330,1331],{"lat":1331,"lon":1330},{"facility":1340,"status":28,"city":1341,"state":28,"zip":1342,"country":1278,"countryCode":1279,"cosmosGeoPoint":1343,"geoPoint":1347,"contacts":28},"Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia","Lviv","79010",{"type":54,"coordinates":1344},[1345,1346],24.02324,49.83826,{"lat":1346,"lon":1345},{"facility":1349,"status":28,"city":1350,"state":28,"zip":1351,"country":1278,"countryCode":1279,"cosmosGeoPoint":1352,"geoPoint":1356,"contacts":28},"Odeska klinichna likarnia na zaliznychnomu transporti filii \"Tsentr okhorony zdorovia\" aktsionernoho","Odesa","65059",{"type":54,"coordinates":1353},[1354,1355],30.74383,46.48572,{"lat":1355,"lon":1354},{"facility":1358,"status":28,"city":1359,"state":28,"zip":1360,"country":1278,"countryCode":1279,"cosmosGeoPoint":1361,"geoPoint":1365,"contacts":28},"Komunalne pidpryiemstvo \"1-a miska klinichna likarnia Poltavskoi miskoi rady\",","Poltava","36039",{"type":54,"coordinates":1362},[1363,1364],34.55367,49.58925,{"lat":1364,"lon":1363},{"facility":1367,"status":28,"city":1368,"state":28,"zip":1369,"country":1278,"countryCode":1279,"cosmosGeoPoint":1370,"geoPoint":1374,"contacts":28},"Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova","Vinnytsia","21018",{"type":54,"coordinates":1371},[1372,1373],28.46871,49.2322,{"lat":1373,"lon":1372},{"type":1376,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[1378,1381],{"name":1379,"class":1380},"Innovative Medicines Initiative","OTHER",{"name":1382,"class":1383},"Biomedical Advanced Research and Development Authority","FED","100311031","phase-3-a-study-to-determine-the-efficacy-safety-and-tolerability-of-aztreonam-avibactam-atm-avi--metronidazole-mtz-versus-meropenem-mer--colistin-col-for-the-treatment-of-serious-infections-due-to-gram-negative-bacteria-100311031",true,"NCT03329092","A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.","A PHASE 3 PROSPECTIVE, RANDOMIZED, MULTICENTER, OPEN-LABEL, CENTRAL ASSESSOR-BLINDED, PARALLEL GROUP, COMPARATIVE STUDY TO DETERMINE THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM (ATM-AVI) ±METRONIDAZOLE (MTZ) VERSUS MEROPENEM±COLISTIN (MER±COL) FOR THE TREATMENT OF SERIOUS INFECTIONS DUE TO GRAM NEGATIVE BACTERIA, INCLUDING METALLO-Β-LACTAMASE (MBL) - PRODUCING MULTIDRUG RESISTANT PATHOGENS, FOR WHICH THERE ARE LIMITED OR NO TREATMENT OPTIONS","REVISIT","Inclusion Criteria:\n\nAll subjects:\n\n1. Male or female from 18 years of age\n2. Provision of informed consent\n3. Confirmed diagnosis of HAP\u002FVAP or cIAI requiring iv antibiotic treatment\n4. Female patients are authorized to participate in this clinical study if criteria concerning pregnancy avoidance stated in the protocol are met and negative pregnancy test\n\nAdditional for cIAI:\n\n1. Diagnosis of cIAI, EITHER:\n\n   Intra-operative\u002Fpostoperative enrolment with visual confirmation of cIAI. OR Preoperative enrollment with evidence of systemic inflammatory response, physical and radiological findings consistent with cIAI; confirmation of cIAI at time of surgery within 24 hours of study entry\n2. Surgical intervention within 24 hours (before or after) the administration of the first dose of study drug\n\nAdditional for HAP\u002FVAP:\n\n1. Onset symptoms \\> 48h after admission to or \\\u003C7 days after discharge from an inpatient care facility\n2. New or worsening infiltrate on CXR or CT scan\n3. Clinical signs and symptoms and laboratory findings consistent with HAP\u002FVAP\n4. Respiratory specimen obtained for Gram stain and culture following onset of symptoms and prior to randomisation\n\nExclusion criteria:\n\nAll subjects:\n\n1. APACHE II score \\> 30\n2. Confirmed or suspected infection caused by Gram-negative species not expected to respond to study drug, or Gram-positive species\n3. Receipt of \\>24 hr systemic antibiotic within 48h prior to randomisation (exception in case of treatment failure)\n4. History of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to aztreonam, carbapenem,monobactam or other β-lactam antibiotics, avibactam, nitroimidazoles or metronidazole, or any of the excipients of the study drugs\n5. Known Clostridium difficle associated diarrhoea\n6. Requirement for effective concomitant systemic antibacterials or antifungals\n7. Creatinine clearance ≤15 ml\u002Fmin or requirement or expectation for renal replacement therapy\n8. Acute hepatitis, cirrhosis, acute hepatic failure, chronic hepatic failure\n9. Hepatic disease as indicated by AST or ALT \\>3 × ULN. Patients with AST and\u002For ALT up to 5 × ULN are eligible if acute and documented by the investigator as being directly related infectious process\n10. Patient has a total bilirubin \\>2 × ULN, unless isolated hyperbilirubinemia is directly related to infectious process or due to known Gilbert's disease\n11. ALP \\>3 × ULN. Patients with values \\>3 × ULN and \\\u003C5 x ULN are eligible if acute and directly related to the infectious process being treated\n12. Absolute neutrophil count \\\u003C500\u002Fmm3\n13. Pregnant or breastfeeding or if of child bearing potential, not using a medically accepted effective method of birth control.\n14. Any other condition that may confound the results of the study or pose additional risks to the subject\n15. Unlikely to comply with protocol\n16. History of epilepsy or seizure disorders excluding febrile seizures of childhood\n\nAdditional for cIAI\n\n1. Diagnosis of abdominal wall abscess; small bowel obstruction or ischemic bowel disease without perforation; traumatic bowel perforation with surgery within 12 hours of diagnosis; perforation of gastroduodenal ulcer with surgery \\\u003C 24 hours of diagnosis primary etiology is not likely to be infectious\n2. Simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis, acute suppurative cholangitis, infected necrotizing pancreatitis, pancreatic abscess\n3. Prior liver, pancreas or small-bowel transplant\n4. Staged abdominal repair (STAR), open abdomen technique or marsupialisation\n\nAdditional for HAP\u002FVAP\n\n1. APACHE II score \\\u003C 10\n2. Known or high likelihood of Gram-positive monomicrobial infection\n3. Lung abscess, pleural empyema, post-obstructive pneumonia\n4. Lung or heart transplant\n5. Myasthenia gravis",false,"ALL","18 Years",{"count":1396,"type":1397},422,"ACTUAL","INTERVENTIONAL",[1400],"PHASE3","A Phase 3 comparative study to determine the efficacy, safety and tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) versus Meropenem (MER) ± Colistin (COL) for the treatment of serious infections due to Gram negative bacteria.",[1403,1404,1405],"Complicated Intra-abdominal Infection","Hosptial Acquired Pneumonia","Ventilator Associated Pneumonia",[1407,1408,1409,1410,1411,1412],"Complicated intra-abdominal infection","Hosptial acquired pneumonia","Ventilator associated pneumonia","Gram negative infections","Metallo-beta lactamase","Multi drug resistant pathogens","COMPLETED","2024-11-19",{"date":1416,"type":1397},"2024-12-10",{"date":1418,"type":1397},"2018-04-05",{"date":1420,"type":1397},"2023-02-23",{"name":5,"class":6},157]