登记号
CTR20140572
相关登记号
曾用名
药物类型
化学药物
临床申请受理号
企业选择不公示
适应症
医院获得性肺炎 / 呼吸机相关性肺炎
试验通俗题目
TR-701 FA与利奈唑胺比较治疗医院内肺炎
试验专业题目
一项3期、随机、双盲研究比较TR-701 FA与利奈唑胺治疗机械通气的革兰阳性细菌感染医院内肺炎
试验方案编号
TR701-132
方案最近版本号
版本日期
方案是否为联合用药
企业选择不公示
申请人信息
申请人名称
联系人姓名
Carisa De Anda
联系人座机
+ 1 913 406 8709
联系人手机号
联系人Email
HABPVABP132@cubist.com
联系人邮政地址
4747 Executive Drive Suite 1100美国
联系人邮编
CA 92121
临床试验信息
试验分类
安全性和有效性
试验分期
III期
试验目的
确定TR 701 FA治疗与利奈唑胺治疗相比在28天全因死亡率（ACM）上的非劣效性（NI）
随机化
随机化
盲法
双盲
试验范围
国际多中心试验
设计类型
平行分组
年龄
18岁(最小年龄)至
无岁(最大年龄)
性别
男+女
健康受试者
无
入选标准
- 诊断为机械通气条件下的医院内肺炎并需要静脉抗生素治疗的患者
- 呼吸系统标本革兰氏染色提示革兰氏阳性菌感染或混合感染，下呼吸道样本培养显示甲氧西林耐药的金黄色葡萄球菌（MRSA）阳性或快速分子诊断试验显示MRSA阳性
排除标准
- 已知或可疑的社区获得性细菌性肺炎或病毒性、真菌性（下呼吸道出现念珠菌不被排除）或寄生虫性肺炎
- 肺部结构异常
- 重度免疫抑制
- 先前连续使用抗生素24小时以上. 过去72小时内，接受对引起VNP的革兰阳性病原菌有效的全身或吸入性抗菌药物治疗，大于24小时
- 预期存活时间＜72小时
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:TR-701 FA（磷酸特地唑胺）
|
用法用量:剂型：冻干粉
给药途径：IV
频率：每天
剂量：200 mg
治疗时间：7或14天
|
对照药
| 名称 | 用法 |
|---|---|
|
中文通用名:Linezolid （利奈唑胺）
|
用法用量:剂型：IV
给药途径：IV
频率：每天2次
剂量：600 mg
治疗时间：10或14天
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 意向治疗分析集的全因死亡率 | 28天 | 有效性指标 |
次要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 微生物学意向治疗分析集的全因死亡率 | 28天 | 有效性指标 |
| 在治愈访视（TOC）时由研究者评估的临床应答率（意向治疗和临床可评估分析集） | 治疗结束后7至14天 | 有效性指标 |
| 甲氧西林敏感性金黄色葡萄球菌或耐甲氧西林金黄色葡萄球菌患者中的全因死亡率 | 28天 | 有效性指标 |
| 微生物学意向治疗集和微生物可评估集-1中比较EOT时微生物良好反应率在 | 治疗结束后1至3天 | 有效性指标 |
| 微生物学意向治疗集和微生物可评估集-2中比较TOC时微生物良好反应率。 | 治疗结束后7至14天 | 有效性指标 |
| 评估磷酸特地唑胺的安全特征并与利奈唑胺进行比较 | 随机分组后32天 | 安全性指标 |
| 评估TR-700的群体药代动力学（PK）和PK/药效学（PD）特征 | 第1天第1次给药，输注A后5至80分钟和4至12小时；第4或5天第7次或9次给药前; 第7天第13次给药后5至80分钟（2份样本） 和第13次给药后4至 12小时 | 有效性指标 |
数据安全监察委员会（DMC）
有
为受试者购买试验伤害保险
有
研究者信息
| 姓名 | 学位 | 职称 | 电话 | 邮政地址 | 邮编 | 单位名称 | |
|---|---|---|---|---|---|---|---|
| Jean Chastre | 教授 | 0142163822 | jean.chastre@psl.aphp.fr | 47-83 boulevard de l'Hospital 5651 Paris Cedex 13, France | 5651 | Service de Reanimation Medicale, Institut de Cardiologie Groupe Hospitalier Pitie-Salpetriere |
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| Institut de Cardiologie Groupe Hospitalier | Jean Chastre | 法国 | Paris | Paris |
| 北京同仁医院 | 刘晓芳 | 中国 | 北京 | 北京 |
| 复旦大学附属华东医院 | 朱惠莉 | 中国 | 上海 | 上海 |
| 上海交通大学附属新华医院 | 郭雪君 | 中国 | 上海 | 上海 |
| 中南大学湘雅二医院 | 陈平 | 中国 | 湖南 | 长沙 |
| 四川大学华西医院 | 梁宗安 | 中国 | 四川 | 成都 |
| 广州医科大学附属第一医院 | 黎毅敏 | 中国 | 广州 | 广州 |
| 江苏省人民医院 | 黄茂 | 中国 | 江苏 | 南京 |
| University of Miami Ryder Trauma Center | Nicholas Namias | 美国 | Florida | Miami |
| Nassau University Medical Center | Louis Riina | 美国 | New York | East Meadow |
| VA Western New York Healthcare System | Ali El Solh | 美国 | New York | Buffalo |
| Lima Memorial Health System | Ravi Kamepalli | 美国 | Ohio | Lima |
| Veterans Caribbean Healthcare System | William Rodriguez Clintron | 美国 | Puerto Rico | San Juan |
| Mercury Street Medical Group Research Department | John Pullman | 美国 | Montana | Butte |
| Harborview Medical Center University of Washington | Miriam Treggiari | 美国 | Washington | Seattle |
| Northwestern Memorial Hospita | Richard Wunderink | 美国 | Illinois | Chicago |
| Cotton O Neil Clinical Research Center | Shawn Magee | 美国 | Kansas | Topeka |
| University of Maryland/R Adams Cowley Shock Trauma Center | Jose Diaz | 美国 | Maryland | Baltimore |
| Virginia Commonwealth University | Ajai Malhotra | 美国 | Virginia | Richmond |
| Christiana Care Health Services | Gearald Fulda | 美国 | Delawre | Newark |
| University of Mississippi Medical Center | Larry Martin | 美国 | Mississippi | Jackson |
| Oklahoma University Health Services Center | Gary Kinasewitz | 美国 | Oklahoma | Oklahoma City |
| Regiannal Medical Center at Memphi | Martin Croce | 美国 | Tenessee | Memphis |
| University Hospitals Case Medical Center | Robert Schilz | 美国 | Ohio | Cleveland |
| University of Toledo | Dawn-Alita Hernandez | 美国 | Ohio | Toledo |
| Department of Internal Mediciine Medical University of Innsbruck | Michael Joannidis | 奥地利 | Innsbruck | Innsbruck |
| Department of Internal Medicine I University of Vienna | Thomas Staudinger | 奥地利 | Vienna | Vienna |
| North Estonia Medical Centre Foundation Intensive Care Centre | Ulo Kivistik | 爱沙尼亚 | Tallinn | Tallinn |
| Blacktown Hospital | Dhaval Ghelani | 澳大利亚 | NSW | Blacktown |
| Prince of Wales Hospital | Yahya Shehabi | 澳大利亚 | NSW | Randwick |
| Monash Medical Centre | David Ernest | 澳大利亚 | Victoria | Clayton |
| Gold Coast Hospital | Brent Richards | 澳大利亚 | Queensland | Southport |
| Wollongong Hospital | Martin Sterba | 澳大利亚 | NSW | Wollongong |
| University Hospital Antwerp | Philippe Jorens | 比利时 | Edegem | Edegem |
| University Hospital Ghent | Pieter Depuydt | 比利时 | Gent | Gent |
| University Hospital Erasme Intensive care department | Jean Lous Vincent | 比利时 | Brussels | Brussels |
| University Hospital Center Charleroi | Patrick Biston | 比利时 | Charleroi | Charleroi |
| Domaine Universitaire du Sart Tilman | Pierre Damas | 比利时 | Liege | Liege |
| Hospital e Maternidade Celso Pierro PUC Campinas | Maria Patelli Lima | 巴西 | Sao Paulo | Campinas |
| Complexo Hospitalar Edmundo Vasconcelos | Artur Timerman | 巴西 | Sao Paulo | Sao Paulo |
| Hospital Felicio Rocho | Maria Eugenia Didier | 巴西 | Minas Gerais | Belo Horizonte |
| Santa Casa de Misericordia de Belo Horizonte | Antonio Tarcisio Freire | 巴西 | Minas Gerais | Belo Horizonte |
| Hospital Sao Lucas da PUCRS | Candida Neves | 巴西 | Rio Grande de Sul | Porto Alegre |
| Hospital Vera Cruz | Carlos Starling | 巴西 | Minas Gerais | Belo Horizonte |
| Hospital do Trabalhador | Alvaro Rea Neto | 巴西 | Parana | Curitiba |
| Santa Casa de Votuporanga | Mauro Esteves Hernandes | 巴西 | Sao Paulo | Votuporanga |
| Helios Hospital Erfurt Department for Anesthesiology Intensive Care & Pain Therapy | Andreas Meier Hellmann | 德国 | Erfurt | Erfurt |
| Vivantes Hospital Neukoelln Clinic for Anesthesiology and Operative Intensive Care and Pain Therapy | Herwig Gerlach | 德国 | Berlin | Berlin |
| Unviversity Hospital Frankurt | Kai Zacharowski | 德国 | Frankurt am Main | Frankurt am Main |
| Universitatsklinikum Hamburg Eppendorf Institut f. Intensive Care | Valentin Fuhrmann | 德国 | Hamburg | Hamburg |
| Universitat des Saarlandes Department of Anesthesiology Intensive Care and Pain Therapy | Thomas Volk | 德国 | Saarland | Saarland |
| University Clinical Hospital Mostar | Zoran Karlovic | 波斯尼亚和黑塞哥维那 | Mostar | Mostar |
| University Clinical Centre Tuzla Clinic for Anesthesiology and Resuscitation | Mirsada Praso | 波斯尼亚和黑塞哥维那 | Tuzla | Tuzla |
| Saint Petersburg State Budgetary Healthcare Institution | Vladimir Simanenkov | 俄罗斯 | Saint Petersburg | Saint Petersburg |
| State Budgetary Healthcare Institution of Novosibirsk | Liubov Shpagina | 俄罗斯 | Novosibirsk | Novosibirsk |
| Moscow State Budgetary Healthcare Institution | Felix Grigoryan | 俄罗斯 | Moscow | Moscow |
| Saint Petersburg State Budgetary Healthcare Institution | Mikhail Sorokin | 俄罗斯 | Saint Petersburg | Saint Petersburg |
| Saint Petersburg State Budgetary Healthcare Institution | Alina Agafyina | 俄罗斯 | Saint Petersburg | Saint Petersburg |
| State Budgetary Healthcare Institution of Novosibirsk | Olga Shevtsove | 俄罗斯 | Novosibirsk | Novosibirsk |
| Regional State Autonomous Healthcare Institution | Liudmila Lenskaya | 俄罗斯 | Tomsk | Tomsk |
| Municipal Institution of Healthcare | Tatyana Martynenko | 俄罗斯 | Barnaul | Barnaul |
| Regional State Budget Healthcare Institution | Vladimir Martynenko | 俄罗斯 | Barnaul | Barnaul |
| State Budgetary Institution Saint-Petersburg I.I. Dzhanelidze Research Institute | Anton Povzun | 俄罗斯 | Saint Petersburg | Saint Petersburg |
| State Budgetary Healthcare Institution of Novosibirsk | Elena Streltsova | 俄罗斯 | Novosibirsk | Novosibirsk |
| Federal State Budgetary Research Institution for Complex Issues of Cardiovascular Diseases | Olga Barbarash | 俄罗斯 | Kemerovo | Kemerovo |
| Russian Academy of Medical Sciences | Konstantin Apartsin | 俄罗斯 | Irkutsk | Irkutsk |
| Federal State Government Institution | Alexander Bezlepko | 俄罗斯 | Moscow | Moscow |
| State budget educational institution of higher professional education | Galina Reshedko | 俄罗斯 | Smolensk | Smolensk |
| State Healthcare Institution of Yaroslavl | Olga Ershova | 俄罗斯 | Yaroslavl | Yaroslavl |
| State Budgetary Healthcare Institution of Novosibirsk | Nadezhda Logvinenko | 俄罗斯 | Novosibirsk | Novosibirsk |
| The Russian National Research University named after N.I. Pirogov | Alexander Upnitsky | 俄罗斯 | Moscow | Moscow |
| State Budgetary Healthcare Institution of Vladimir | Mikhail Simirnov | 俄罗斯 | Vladimir | Vladimir |
| State City Hospital #36 | Boris Berezhanskiy | 俄罗斯 | Moscow | Moscow |
| Ryazan State Medical University on the base of Ryazan Regional Clinical Hospital | Vladimir Abrosimov | 俄罗斯 | Ryazan | Ryazan |
| Centre Hospitalier Universitaire Dupuytren Service de Reanimation Polyvalente | Marc Clavel | 法国 | Limoges | Limoges |
| Hopital de la Conception Service d Anesthesie Reanimation | Jacques Albanese | 法国 | Marseille | Marseille |
| Hopital Pierre Wertheimer Service d Anesthesie Reanimation | Frederic Dailler | 法国 | Bron | Bron |
| Hopital Albert Michallon Service de Reanimation Medicale | Carole Schwebel | 法国 | Grenoble | Grenoble |
| Reanimation DRIS Hopital Nord AP HM | Laurent Papazian | 法国 | Marseille | Marseille |
| Centre Hospitalier Universitairede Rennes Pontchaillou Service Anesthesie Reanimation | Philippe Seguin | 法国 | Rennes | Rennes |
| ervice de Reanimation Polyvalente unite de soins continus Centre hospitalier | Arnaud Desachy | 法国 | Angouleme | Angouleme |
| Service de Reanimation medicale CHU Poitiers La miletrie | Rene Robert | 法国 | Poitiers | Poitiers |
| Centre Hospitalier Regional d Orleans Hopital | Thierry Boulain | 法国 | Orleans | Orleans |
| Service de reanimation CENTRE HOSPITALIER LYON SUD | Alain Lepape | 法国 | Pierre Benite | Pierre Benite |
| Reanimation Polyvalente CH Victor DUPOUY | Gaetan Plantefeve | 法国 | Argenteuil | Argenteuil |
| Service d Anesthesie et de Reanimation Centre Hospitalier Universitaire d Amiens | Herve Dupont | 法国 | Amiens | Amiens |
| Fundacion Cardioinfantil Instituto de Cardiologia | Abraham Ali | 哥伦比亚 | Bogota D.C | Bogota D.C |
| Hospital Pablo Tobon Uribe | Carlos Alberto Cadavid | 哥伦比亚 | Antioquia | Medellin |
| West Visayas State University Medical Center | Marie Isidro | 菲律宾 | Iloilo | Iloilo |
| Las Pinas Doctors Hospital | Mary Jane Sandagon | 菲律宾 | Las Pinas | Las Pinas |
| Philippine General Hospital | Lenora Canizares Fernandez | 菲律宾 | Manila | Manila |
| Chinese General Hospital and Medical Center | Bernice Dela Cruz | 菲律宾 | Quezon Manila | Quezon Manila |
| Quirino Memorial Medical Center | Joel Santiaguel | 菲律宾 | Quezon | Quezon |
| Emergency Surgery and Traumatology Center | Revaz Tabukashvili | 格鲁吉亚 | Tbilisi | Tbilisi |
| High Technology Medical Center University Clinic | George Ingorokva | 格鲁吉亚 | Tbilisi | Tbilisi |
| Academician O.Gudushauri National Medical Center | Nikoloz Kartsivadze | 格鲁吉亚 | Tbilisi | Tbilisi |
| Georgian Patriarchate St. Joachim and St.Ann Medical Center | Tamar Gvarjaladze | 格鲁吉亚 | Tbilisi | Tbilisi |
| West Georgian Natiaonal Center of Interventional Medicine Named Academician Z. Tskhakaia | Irakli Panchulidze | 格鲁吉亚 | Kutaisi | Kutaisi |
| Vakhtang Bochorishvili Antiseptic Center | Manana Makhviladze | 格鲁吉亚 | Tbilisi | Tbilisi |
| Republican Research Center for Emergency Medicine | Agzam S. Zhumadilov | 哈萨克斯坦 | Astana | Astana |
| State public institution under economic jurisdiction | Tleuberdy K. Kuandykov | 哈萨克斯坦 | Almaty | Almaty |
| Almaty State Institute of Advanced Medical Education based on the State public institution | Murat Zhanuzakov | 哈萨克斯坦 | Almaty | Almaty |
| Yonsei University College of Medicine | Moo Suk Park | 韩国 | Seoul | Seoul |
| Gachon University Gil Medical Center | Seong-hwan Jeong | 韩国 | Incheon | Incheon |
| SMG-SNU Boramae Medical Center | Deog Kyeom Kim | 韩国 | Seoul | Seoul |
| Chung-Ang University Hospital | Jay Yeol Kim | 韩国 | Seoul | Seoul |
| St. Paul's Hospital | Sang Haak Lee | 韩国 | Seoul | Seoul |
| Kyung Hee University Medical Center | Myung Jae Park | 韩国 | Seoul | Seoul |
| Korea University Guro Hospital | Jae Jeong Shim | 韩国 | Seoul | Seoul |
| Asan Medical Center | Sang-Bum Hong | 韩国 | Seoul | Seoul |
| Konkuk University Medical Center | Sun Jong Kim | 韩国 | Seoul | Seoul |
| Seoul National Hospital University | Sang Min Lee | 韩国 | Seoul | Seoul |
| Seoul St. Mary's hospital The Catholic Univ. | Seok Chan Kim | 韩国 | Seoul | Seoul |
| Catholic University of Korea, Incheon St Mary | Ju Sang Kim | 韩国 | Incheon | Incheon |
| Queen Elizabeth II Health Sciences Center | Richard Hall | 加拿大 | Nova Scotia | Halifax |
| Winnipeg Health Sciences Centre | Faisal Siddiqui | 加拿大 | Manitoba | Winnipeg |
| Kingston General Hospital | John Muscedere | 加拿大 | Ontario | Kingston |
| St. Paul's Hospital | John Boyd | 加拿大 | British Columbia | Vancouver |
| Foothill's Medical Centre | Paul Boucher | 加拿大 | Alberta | Calgary |
| Hopital Charles-Lemoyne Charles Lemoyne Hospital Research Center | Germain Poirier | 加拿大 | Quebec | Greenfield Park |
| Peter Lougheed Centre | Dan Zuege | 加拿大 | Alberta | Calgary |
| Royal Alexandra Hospital | J. Kutsogiannis | 加拿大 | Alberta | Edmonton |
| Royal Jubilee Hospital | Gordon Wood | 加拿大 | British Columbia | Victoria |
| Internal Medicine-Metabolic Care and Gerontology University Hospital Hradec Kralove | Jan Manak | 捷克 | Hradec Kralove | Hradec Kralove |
| Anaesthesiology and Intensive Care Medicine University Hospital Kralovske Vinohrady | Jan Pachl | 捷克 | Prague 10 | Prague 10 |
| Neurology, Intensive Care Medicine University Hospital Ostrava | Petr Hon | 捷克 | Ostrava - Poruba | Ostrava - Poruba |
| Clinical Hospital Dubrava | Ino Husedzinovic | 克罗地亚 | Zagreb | Zagreb |
| Clinical Hospital Centre Zagreb, Clinic for Internal Medicine, Institute of intensive medicine | Ivan Gornik | 克罗地亚 | Zagreb | Zagreb |
| Institute of neuroinfections and intensive care unit | Bruno Barsic | 克罗地亚 | Zagreb | Zagreb |
| Liepaja Regional Hospital Anaesthesiology and Intensive Care Uni | Ivars Krastins | 拉托维亚 | Liepaja | Liepaja |
| Riga East Clinical University Hospital State Burn Center, Intensive Care Department | Andrejs Levins | 拉托维亚 | Riga | Riga |
| Riga East Clinical University Hospital Toxicology and sepsis clinic | Olegs Suba | 拉托维亚 | Riga | Riga |
| Hammoud Hospital University Medical Center | Zena Hammound | 黎巴嫩 | Saida | Saida |
| Rafik Hariri University Hospital | Oussaima El Dbouni | 黎巴嫩 | Beirut | Jnah |
| Ain Wazein Hospital | Rima Moghnieh | 黎巴嫩 | El Chouf | El Chouf |
| Pusat Perubatan Universiti Malaya (PPUM)/University Dept of Anaesthesia, Faculty of Medicine | Vineya Rai Hakumat Rai | 马来西亚 | Kuala Lumpur | Kuala Lumpur |
| Penang Hospital | Chow Ting Soo | 马来西亚 | Georgetown Pulau Penang | Georgetown Pulau Penang |
| Hospital Umum Sarawak/Sarawak General Hospital | Norzalina Binti Esa | 马来西亚 | Sarawak | Kuching |
| Hospital Raja Permaisuri Bainun | Kit Weng Foong | 马来西亚 | Perak Darul Ridzuan | Perak Darul Ridzuan |
| Institut Jantung Negara/National Heart Center | Suneta Sulaiman | 马来西亚 | Suneta Sulaiman | Suneta Sulaiman |
| Hospital Nivel IV Edgardo Rebagliati Martins | Martin Oyanguren | 秘鲁 | Lima 11 | Lima 11 |
| Hospital Nivel IV Guillermo Almenara Irigoyen | Ruben Eli Huaman Quezada | 秘鲁 | Lima 13 | Lima 13 |
| Hospital Maria Auxiliadora | Cristhian Juan Galvez Vasquez | 秘鲁 | Lima 18 | Lima 18 |
| Hospital Nacional Arzobispo Loayza | Eduardo Demetrio Matos Prado | 秘鲁 | Lima 1 | Lima 1 |
| Hospital Nacional Adolfo Guevara Velasco | Maria Edelmira Cruz Saldarriaga | 秘鲁 | Cusco | Cusco |
| Hospital Nacional Carlos Alberto Seguin Escobedo-ESSALUD-Arequipa | Luis Fajardo | 秘鲁 | Arequipa | Arequipa |
| Hospital Central de la Fuerza Aerea del Peru | Manuel Jesus Mayorga Espichan | 秘鲁 | Lima 18 | Lima 18 |
| Hospital Civil | Eduardo Rodriguez Noriega | 墨西哥 | Jalisco | Guadalajara |
| Hospital General de Mexico | Pablo Duarte | 墨西哥 | Mexico, DF. | Mexico, DF. |
| Hospital Civil | Daniel Rodriguez Gonzalez | 墨西哥 | Jalisco | Guadalajara |
| Hospital Central | Martin Magaa | 墨西哥 | San Luis Potosi | San Luis Potosi |
| Centro Medico Adolfo Lopez Mateos | Rodrigo Suarez | 墨西哥 | Mexico, DF. | Mexico, DF. |
| Medical Intensive Care Unit, University Hospital Zurich | Marco Maggiorini | 瑞士 | Zurich | Zurich |
| Boland Ethical Research Group | Christo van Dyk | 南非 | Worcester | Worcester |
| Charlotte Maxeke Academic Hospital Department of Surgery | Gavin Jacks | 南非 | Parktown West | Parktown West |
| Netcare Union Hospital | Frank Plani | 南非 | Johannesburg | Johannesburg |
| Greys Hospital | Kriyananda Naidoo | 南非 | Pitermaritzburg | Pitermaritzburg |
| Helen Joseph Hospital Intensiv Care Department | Murimisi Mukansi | 南非 | Auckland Park | Auckland Park |
| Mediclinic Kloof | Francois Erasmus | 南非 | Pretoria | Pretoria |
| Netcare Milpark Hospital ICU Ground Floor | Kenneth Boffard | 南非 | Johannesburg | Johannesburg |
| Universitas Hospital Department Critical Care | Anwar Hoosen | 南非 | Bloemfontein | Bloemfontein |
| Clinic for Urgent Pulmonology, Institute for Pulmonary Diseases of Vojvodina | Jovan Matijasevic | 塞尔维亚 | Sremska Kamenica | Sremska Kamenica |
| Center for Anesthesiology and Reanimation Clinical Centre Kragujevac | Jasna Jevdjic | 塞尔维亚 | Kragujevac | Kragujevac |
| Clinic for Cardiac Surgery Clinical Center of Serbia | Miljko Ristic | 塞尔维亚 | Belgrade | Belgrade |
| Clinical for Digestive Surgery-First Surgery Clinic Clinical Center of Serbia | Ivan Palibrk | 塞尔维亚 | Belgrade | Belgrade |
| Clinic for Neurosurgery Clinical Center of Serbia | Branko Milakovic | 塞尔维亚 | Belgrade | Belgrade |
| Emergency Center Clinical Center of Serbia | Vesna Bumbasirevic | 塞尔维亚 | Belgrade | Belgrade |
| Clinic of Anesthesiology and Intensive Therapy Military Medical Academy | Maja Surbatovic | 塞尔维亚 | Belgrade | Belgrade |
| Teaching Hospital Peradeniya | Vasnthi Pinto | 斯里兰卡 | Peradeniya | Peradeniya |
| Colombo North Teaching Hospital | Asantha de Silva | 斯里兰卡 | Ragama | Ragama |
| Kandy Teaching Hospital | Ravi Weerakoon | 斯里兰卡 | Kandy | Kandy |
| I.klinika anesteziologie a intenzivnej mediciny Univerzitna nemocnica L. Pasteura Kosice | Jozef Firment | 斯洛伐克 | Kosice | Kosice |
| Klinika anesteziologie a intenzivnej mediciny Univerzitna nemocnica Martin | Beata Saniova | 斯洛伐克 | Martin | Martin |
| Taichung Veterans General Hospital | Ming-Cheng Chan | 中国 | Taichung | Taichung |
| China Medical University Hospital | Chih Yen Tu | 中国 | Taichung | Taichung |
| Chang Gung Memorial Hospital | Shaw Wei Leu | 中国 | Chiayi | Puzi City |
| E-Da Hospital Pulmonary Division, Dept of Internal Medicine | Yu-Feng Wei | 中国 | Kaohsiung | Kaohsiung |
| Chang Gung Memorial Hospital | Kuo Chin Kao | 中国 | Taoyuan | Taoyuan |
| Hacettepe University Medical Faculty, Department of Internal Disease, Infectious Diseases Unit | Ismail Balik | 土耳其 | Sihhiye Ankara | Sihhiye Ankara |
| Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital | Filiz Kosar | 土耳其 | Zeytnburnu Istanbul | Zeytnburnu Istanbul |
| Hacettepe University Medical Faculty, Department of Internal Disease, Infectious Diseases Unit | Serhat Unal | 土耳其 | Sihhiye Ankara | Sihhiye Ankara |
| Osmangazi University Medical Faculty Department of Infectious Diseases | Gaye Usler | 土耳其 | Eskisehir | Eskisehir |
| Karadeniz Technical University Medical Faculty Farabi Hospital | Iftihar Koksal | 土耳其 | Trabzon | Trabzon |
| Ege University Medical Faculty Department of Infectious Diseases and Clinical Microbiology | Sercan Ulusoy | 土耳其 | Bornova Izmir | Bornova Izmir |
| Maharaj Nakorn Chiangmai Hospital | Chaicharn Pothirat | 泰国 | Chiangmai | Chiangmai |
| Sororaj Hospital | Methee Chayakulkeeree | 泰国 | Bangkok | Bangkok |
| Songklanagarind Hospital | Sutep Jaruratanasirikul | 泰国 | Songkla | Songkla |
| Phramongkutklao Hospital | Virissorn Wongsrichanalai | 泰国 | Rajathevi | Rajathevi |
| Srinagarind Hospital | Piroon Mootsikapun | 泰国 | Khon Kaen | Khon Kaen |
| Bamrasnaradura Infectious Diseases Institute | Weerawat Manosuthi | 泰国 | Nonthaburi | Nonthaburi |
| Clinica de Enfermedades Infecciosas Departamento de Medicina Interna Hospital Roosevelt | Carlos Rodolfo Mejia Villatoro | 危地马拉 | Ciudad de Guatemala | Ciudad de Guatemala |
| Centro Medico Militar | Luis Gonzalez | 危地马拉 | Ciudad de Guatemala | Ciudad de Guatemala |
| Sanatorio Nuestra Seora del Pilar | Hugo Pezzarossi | 危地马拉 | Ciudad de Guatemala | Ciudad de Guatemala |
| Hospital Universitario Esperanza | Edgar Lopez | 危地马拉 | Ciudad de Guatemala | Ciudad de Guatemala |
| Kharkiv Medical Academy of Postgraduate Education, Municipal establishment of Healthcare | Vadim Nikonov | 乌克兰 | Kharkiv | Kharkiv |
| National medical university after name O.O.Bogomolets, Kyiv city municipal hospital #17 | Feliks Glumcher | 乌克兰 | Kyiv | Kyiv |
| Kyiv Clinical Emergency Municipal Hospital | Igor Shlapak | 乌克兰 | Kyiv | Kyiv |
| MMI Clinical Rudnichna hospital | Andrey Kolesnikov | 乌克兰 | Makeevka | Makeevka |
| Ivano-Frankivsk Regional Clinical Hospital | Ivan Titov | 乌克兰 | Ivano-Frankivsk | Ivano-Frankivsk |
| Institute of general and emergency surgery of the National academy of sciences of Ukraine | Aleksandr Pavlov | 乌克兰 | Kharkiv | Kharkiv |
| Lugansk State Medical University, based on Lugansk Regional Clinical Hospital | Yuriy Nalapko | 乌克兰 | Tbilisi | Tbilisi |
| Ukrainian Medical Stomatological Academy, based on 1st Poltava City clinical Hospital | Igor Kaydashev | 乌克兰 | Poltava | Poltava |
| Hospital Clinico San Carlos Servicio de Medicina Intensiva | Miguel Sanchez | 西班牙 | Madrid | Madrid |
| Hospital Universitari Vall d Hebron Servicio de Medicina Intensiva | Jordi Rello | 西班牙 | Barcelona | Barcelona |
| Consorci Sanitari Parc de Salt de Barcelona-Hospital del Mar Unidad de Cuidados Intensivos pl. Baja | Yolanda Diaz | 西班牙 | Barcelona | Barcelona |
| Hospital Universitari Joan XXIII Unidad de Cuidados Intensivos 1 planta | Alejandro Rodriguez | 西班牙 | Tarragona | Tarragona |
| Hospital del Vinalopo Unidad de Cuidados Intensivos | Rafael Carrasco | 西班牙 | Altcante | Altcante |
| Hospital General Universitario Alicante C/ Pintor Baeza | Esperanza Merino | 西班牙 | Altcante | Altcante |
| Hospital Universitario de Son Espases | Jose Ignacio Ayestaran | 西班牙 | Altcante | Altcante |
| Hospital De Torrevieja Unidad De Cuidados Intensivos | Eugenio Herrero Gutierrez | 西班牙 | Altcante | Altcante |
| Hospital Universitari de Bellvitge Servicio de Medicina Intensiva | Rafael Maez Mendiluce | 西班牙 | Llobregat | Llobregat |
| Hospital Son Llatzer Servicio De Medicina Intensiva | Lorenzo Socias Crespi | 西班牙 | Islas Baleares | Islas Baleares |
| Hospital Clinic i Provincial de Barcelona Servicio de Pneumologia | Antoni Torres Marti | 西班牙 | Barcelona | Barcelona |
| Hospital Universitario de Torrejon Servicio de Medicina Intensiva | Maria Cruz Martin Delgado | 西班牙 | Torrejon de Ardoz | Torrejon de Ardoz |
| Hospital Gregorio Maranon University Of Madrid | Emilio Bouza | 西班牙 | Madrid | Madrid |
| Hospital Universitari Mutua Terrassa | Ricard Ferrer Roca | 西班牙 | Barcelona | Barcelona |
| University General Hospital of Larissa Critical Care Department | Epaminondas Zakynthinos | 希腊 | Viopolis | Viopolis |
| 251 General Airforce Hospital Intensive Care Unit | Georgios Anthopoulos | 希腊 | Athens | Athens |
| University General Hospital of Thessaloniki AHEPA Intensive Care Unit | Helen Gkeka | 希腊 | Thessaloniki | Thessaloniki |
| General Hospital of Athens EVANGELISMOS A Department of Critical Care and Pulmonary Services | Spyros Zakynthinos | 希腊 | Athens | Athens |
| University General Hospital of Athens ATTIKON 2nd Critical Care Department | Apostolos Armaganidis | 希腊 | Athens | Athens |
| General Hospital of Thessaloniki G. PAPANIKOLAOU Respiratory Failure Unit | Paraskevi Pataka-Aryropoulou | 希腊 | Thessaloniki | Thessaloniki |
| Queen Mary Hospital | Simon Sin | 中国 | Hong Kong | Hong Kong |
| Cantebury District Health Board | Seton Henderson | 新西兰 | Christchurch | Christchurch |
| Auckland City Hospital | Shay McGuinness | 新西兰 | Grafton Auckland | Grafton Auckland |
| Hawke's Bay Hospital | Ross Freebairn | 新西兰 | Hastings | Hastings |
| Szent Imre Oktato Korhaz, Intenziv Terapias Osztaly | Csaba Fejer | 匈牙利 | Budapest | Budapest |
| Fejer Megyei Szent Gyorgy Korha, Intenziv Terapias Osztaly | Agnes Sarkany | 匈牙利 | Seregelyesi | Seregelyesi |
| Bajcsy-Zsilinszky Korhaz, Intenziv es Sürgossegi Osztaly | Barbara Volgyes | 匈牙利 | Budapest | Budapest |
| Szegedi Tudomanyegyetem aOK Aneszteziologiai es Intenziv Terapias Inteze | Zsolt Molnar | 匈牙利 | Szeged | Szeged |
| Kettering General Hospital Research Department | Philip Watt | 英国 | Kettering | Kettering |
| Leeds Teaching Hospitals NHS Trust | Mark Bellamy | 英国 | Leeds | Leeds |
| Intensive Care Unit Emek Medical Center | Amiram Lev | 以色列 | Afula | Afula |
| Intesnsive Care Unit Kaplan Medical Center | Elena Kishinevsky | 以色列 | Rehovot | Rehovot |
| Infectious Diseases Unit Chaim Sheba Medical Center | Galia Rahav | 以色列 | Ramat-Gan | Ramat-Gan |
| Intensive Care Unit Hadassah Medical Cente | Phillipe Levin | 以色列 | JerUSlem | JerUSlem |
| Departtment of Critical Care Medicine Rambam Health Campus | Yaron Bar-Lavie | 以色列 | Haifa | Haifa |
| King Abdullah University Hospital Infectious Disease Department | Basheer Khasawneh | 约旦 | Irbid | Irbid |
| King Abdullah University Hospital Critical Care Department | Shaher Samrah | 约旦 | Irbid | Irbid |
| University of Leipzig Department of Anesthesiology and Intensive Care Medicine Medical Faculty | Udo X. Kaisers | 德国 | Leipzig | Leipzig |
| Hospital Augsburg Clinic for Anesthesiology and Operative Intensive Care SepNet Regional Centre | Ulrich Jaschinski | 德国 | Augsburg | Augsburg |
| Alegent Creighton Research Clinic of Creighton University Medical Center | Lee Morrow | 美国 | Nebraska | Omaha |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto | Suzana Lobo | 巴西 | Sao Paulo | Sao Jose do Rio Preto |
| 北京朝阳医院 | 童朝晖 | 中国 | 北京 | 北京 |
| 贵州省人民医院 | 张湘燕 | 中国 | 贵州 | 贵阳 |
| 浙江大学医学院附属第一医院 | 周建英 | 中国 | 浙江 | 杭州 |
| 海南省人民医院 | 黄奕江 | 中国 | 海南 | 海口 |
| 第三军医大学新桥医院 | 王长征 | 中国 | 重庆 | 重庆 |
| 浙江大学医学院附属邵逸夫医院 | 应可净 | 中国 | 浙江 | 杭州 |
| 中山大学附属第三医院 | 吴本权 | 中国 | 广东 | 广州 |
| 中山大学附属第一医院 | 曾勉 | 中国 | 广东 | 广州 |
| 上海交通大学医学院附属瑞金医院 | 时国朝 | 中国 | 上海 | 上海 |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| 广州医科大学附属第一医院医学伦理委员会 | 同意 | 2014-11-27 |
| 广州医科大学附属第一医院医学伦理委员会 | 同意 | 2017-05-12 |
试验状态信息
试验状态
已完成
目标入组人数
国内: 100 人；
国际: 726 人；
已入组例数
国内: 登记人暂未填写该信息；
国际: 登记人暂未填写该信息；
实际入组总例数
国内: 18 人 ；
国际: 726 人；
第一例受试者签署知情同意书日期
国内：登记人暂未填写该信息；
国际：登记人暂未填写该信息；
第一例受试者入组日期
国内：2015-12-04；
国际：2014-06-19；
试验终止日期
国内：2018-01-04；
国际：2018-06-22；
临床试验结果摘要
| 版本号 | 版本日期 |
|---|
