422
Participants
Start Date
April 5, 2018
Primary Completion Date
February 23, 2023
Study Completion Date
February 23, 2023
ATM-AVI
"(Creatinine clearance \> 50 mL/min) 6500 mg ATM/2167 mg (loading dose, extended loading dose and maintenance dose) by iv infusion on Day 1 followed by a total daily dose of 6000 mg ATM/2000 mg AVI~(Creatinine clearance 31 - 50 mL/min) 4250 mg ATM/1417 mg AVI on Day 1 (loading dose, extended loading dose, maintenance dose) followed by total daily dose 3000 mg ATM/1000 mg AVI~(Creatinine clearance 16 - 30 mL/min) 2700 mg ATM/900 mg AVI on Day 1 (loading dose, extended loading dose maintenance dose), followed by total daily dose 2025 mg ATM/675 mg AVI"
MTZ
For cIAI only; 500 mg/100 mL metronidazole iv infusion over 1hr q8h
MER
"Where pathogen initially not suspected of being MER-resistant:~(Creatinine clearance \> 50 mL/min) 1000 mg meropenem by 30 min iv infusion q8h~(Creatinine clearance 26 - 50 mL/min) 1000mg meropenem by 30 min iv infusion q12h~(Creatinine clearance 16 - 25 mL/min) 500 mg meropenem by 30 min iv infusion q12h~Where pathogen initially suspected of being MER-resistant (Creatinine clearance \> 50 mL/min) 2000 mg meropenem by 180 min iv infusion q8h~(Creatinine clearance 26 - 50 mL/min) 2000 mg meropenem by 180 min iv infusion q12h~(Creatinine clearance 16 - 25 mL/min) 1000 mg meropenem by 180 min iv infusion q12h"
COL
"Loading dose 9 million IU by 30 -60 min iv infusion (6 million IU where weight \< 60 kg) followed by one of the following maintenance doses:~(Creatinine clearance \> 50 mL/min) after a 12h interval, commence maintenance dosing 9 million IU daily in 2 or 3 divided doses by 30 -60 min iv infusions.~(Creatinine clearance 31 - 50 mL/min) After a 24 hr interval, commence maintenance dosing of 6 million IU daily in 2 divided doses by 30 -60 min iv infusion~(Creatinine clearance 21 - 30 mL/min) After a 24 hr interval, commence maintenance dosing 5 million IU daily in 2 divided doses by 30 -60 min iv infusion~(Creatinine clearance 16 - 20 mL/min) after a 24 hr interval, commence maintenance dosing 4 million IU daily in 2 divided doses by 30 -60 min iv infusion"
Taipei Municipal Wanfang Hospital, Taipei
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City
Philippine General Hospital, Central Intensive Care Unit, Manila
Quirino Memorial Medical Center, Quezon City
St. Luke's Medical Center, Quezon City
Makati Medical Center, Makati City
University Hospital Alexandrovska, Clinic of Anesthesiology and Intensive Care, Sofia
University Hospital Queen Joanna ISUL, Clinic of Surgery, Sofia
Asian Hospital and Medical Center, City of Muntinlupa
Sanatorio Britanico, Rosario
Baguio General Hospital and Medical Center, Baguio City
De La Salle Medical and Health Sciences Institute, City of Dasmarinas
Hospital San Roque, Córdoba
St. Paul's Hospital of Iloilo, Inc., Iloilo City
West Visayas State University Medical Center, Iloilo City
University Multiprofile Hospital for Active Treatment ''Prof.Dr Stoyan Kirkovich''AD, Stara Zagora
Davao Doctors Hospital, Davao City
Klinicka bolnica Merkur, Zagreb
Clinical Hospital Dubrava, Zagreb
National Taiwan University Hospital, Taipei
"General Hospital of Athens Evangelismos", Athens
Faculty of Medicine Siriraj Hospital, Bangkoknoi
Bamrasnaradura Infectious Disease Institute (BIDI), Muang
"General and Chest Diseases Hospital Sotiria", Athens
"General Hospital of Athens Laiko", Athens
"University General Hospital ATTIKON", Athens
Hospital Seberang Jaya, Seberang Jaya
Hospital Universitario Reina Sofia, Córdoba
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan
Hospital Sultanah Nur Zahirah, Kuala Terengganu
Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova, Vinnytsia
Gachon University Gil Medical Center - Infectious Disease, Incheon
Hospital Universitario Ramon y Cajal, Madrid
Hospital Regional Universitario de Malaga, Málaga
University Hospital Centre Osijek, Osijek
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), Presidio Ospedaliero Universitario Santa, Udine
Acibadem Atakent Hospital, Istanbul
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi, Istanbul
"General Hospital Dr. Josip Bencevic Slavonski Brod", Slavonski Brod
Ege University Faculty of Medicine, Izmir
"Komunalne pidpryiemstvo 1-a miska klinichna likarnia Poltavskoi miskoi rady,", Poltava
Complejo Hospitalario Universitario de Vigo. Area Sanitaria de Vigo. Hospital Alvaro Cunqueiro, Vigo
Srinagarind Hospital, Division of Infectious Disease and Tropical Medicine, Muang
Krajska zdravotni, a.s. - Nemocnice Decin, o.z., Děčín
Lekarna Nemocnice Decin, Krajska zdravotni, a.s.- Nemocnice Decin, o.z., Děčín
Taichung Veterans General Hospital, Taichung
Hospital Universitario Virgen Macarena, Seville
Hospital Universitario Virgen del Rocio, Seville
University General Hospital of Larissa, Larissa
Azienda Ospedaliero Universitaria di Modena, Modena
Farmacia Ospedaliera - Direzione Assistenza Farmaceutica, Modena
SC di Radiologia - Azienda Ospedaliera Universitaria di Modena, Modena
Koutlimbaneio and Triantafylleio General Hospital of Larissa, Larissa
Kocaeli University Medical Faculty, Kocaeli
Hospital Civil Fray Antonio Alcalde, Guadalajara
Hospital Universitari i Politecnic la Fe, Valencia
"KZ Dnipropetrovska oblasna klinichna likarnia im. I.I. Mechnykova, viddilennia khirurhii №2", Dnipro
"Komunalnyi zaklad Miska klinichna likarnia No.4 Dniprovskoi miskoi rady, viddilennia profpatolohii", Dnipro
Hospital Universitario Miguel Servet, Zaragoza
Klinicki bolnicki centar Rijeka, Rijeka
Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello, Pisa
UO Radiognastostica 2 Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello, Pisa
UO Farmaceutica Azienda Ospedaliero-Universitaria Pisana, Pisa
"OKU Chernivetska oblasna klinichna likarnia, khirurhichne viddilennia", Chernivtsi
University Malaya Medical Centre, Kuala Lumpur
Karadeniz Technical University Medical Faculty Farabi Hospital, Trabzon
"DU Instytut zahalnoi ta nevidkladnoi khirurhii imeni V.T. Zaitseva Natsionalnoi akademii medychnykh", Kharkiv
Southern Illinois University School of Medicine, Springfield
Memorial Medical Center, Springfield
National Taiwan University Hospital Yun-Lin Branch, Douliu
"Hospital Universitario Dr. Jose Eleuterio Gonzalez", Monterrey
"Odeska klinichna likarnia na zaliznychnomu transporti filii Tsentr okhorony zdorovia aktsionernoho", Odesa
University General Hospital of Heraklion, Heraklion, Crete
Azienda Ospedaliero-Universitaria Ospedali Riuniti, Foggia
Oblasna klinichna likarnia, viddilennia anesteziolohii ta intensyvnoi terapii, Ivano-Frankivsk
Ivano-Frankivska tsentralna miska klin likarnia, viddilennia khirurhii,, Ivano-Frankivsk
Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia, Lviv
Kaohsiung Veterans General Hospital, Kaohsiung City
Banner University Medical Center - Tucson, Tucson
Songklanagarind Hospital, Prince of Songkla University, Hat Yai
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance
Harbor-UCLA Medical Center, Torrance
Peking University People's Hospital, Beijing
Peking University Third Hospital, Beijing
Dayanand Medical College and Hospital, Ludhiana
"FGBOU VO The First St. Petersburg state medical university n. a. I.P. Pavlova", Saint Petersburg
Huashan Hospital, Fudan University, Shanghai
Shanghai Pulmonary Hospital, Shanghai
Affiliated Hospital of Jiangsu University, Zhenjiang
"OGBUZ Smolensk Regional Clinical Hospital", Smolensk
"FSBEI of HE Smolensk State Medical University of the Ministry of Health of the RF", Smolensk
Scientific Research Institute of Antimicrobial Chemotherapy, Smolensk
Jiangyin People's Hospital, Jiangyin
Jiangyin People's Hospital, Jiangyin
King George's Medical University, Lucknow
Tianjin Union Medical Center, Tianjin
"Spitalul Clinic Judetean de Urgenta Pius Brinzeu", Timișoara
S.R. Kalla Memorial Gastro & General Hospital, Jaipur
The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou
Taizhou Hospital of Zhejiang Province, Linhai
Lishui People's Hospital, Lishui
Quzhou People's Hospital, Quzhou
"State Budgetary Healthcare Institution Regional Clinical Hospital No. 2 of the Ministry of Health", Krasnodar
Zhangzhou Municipal Hospital of Fujian Province, Zhangzhou
Spitalul Clinic de Boli Infectioase Cluj-Napoca, Cluj-Napoca
Changsha Third Hospital, Changsha
Hunan Province People's Hospital, Changsha
Deenanath Mangeshkar Hospital And Research Centre, Pune
Sahyadri Super Speciality Hospital, Pune
Sahyadri Super Specialty Hospital, Pune
Sahyadri Clinical Research & Development Center, Pune
"Private Healthcare Institution Clinical Hospital 'Russian Railroad Medicine, Chelyabinsk'", Chelyabinsk
ZhuJiang Hospital of Southern Medical University, Guangzhou
The First Affiliated Hospital of Shantou University Medical College, Shantou
The Second People's Hospital of Shenzhen, Shenzhen
King George Hospital, Visakhapatnam
Nanning First People's Hospital, Nanning
Affiliated Hospital of Guilin Medical University, Guilin
Victoria Hospital, Bangalore Medical College and Research Institute, Bangalore
M S Ramaiah Medical College and Hospitals, Bangalore
JSS Hospital, Mysuru
Kasturba Medical College and Hospital, Manipal
Apollo Hospitals, Chennai
"State autonomous institution of healthcare of the Perm Region City clinical hospital #4", Perm
"GBUZ of Novosibirsk region City Clinical Hospital # 2", Novosibirsk
The First people's Hospital of Kunming, Kunming
Government Medical College, Kozhikode, Kozhikode
Amrita Institute of Medical Sciences & Research Centre, Kochi
"Spitalul Clinic de Boli Infectioase Sf. Parascheva Iasi", Iași
Rambam Health Care Campus, Haifa
Rabin Medical Center, Beilinson Hospital, Petah Tikva
The Chaim Sheba Medical Center, Tel Litwinsky
Tel Aviv Sourasky Medical Center, Tel Aviv
Shamir Medical Center, Infectious Diseases Unit, Ẕerifin
Assuta Ashdod University Hospital, Ashdod
Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem, Jerusalem
Sanatorio Servicios Medicos SM, Santo Tomé
Baotou Central Hospital, Baotou
Fakultni nemocnice Brno, Brno
Public Hospital Kolin, a.s., Kolin III
Nemocnice Kyjov, prispevkova organizace, Kyjov
Fakultni nemocnice Kralovske Vinohrady, Prague
Sahyadri Specialty Hospital, Pune
"Institutul National de Boli Infectioase Prof. Dr. Matei Bals", Bucharest
"Spitalul Clinic de Boli Infectioase si tropicale Dr. Victor Babes", Bucharest
Seoul National University Hospital, Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital, Seoul
Hallym University Kangnam Sacred Heart Hospital, Seoul
Hospital Universitari Germans Trias i Pujol, Badalona
Hospital Universitario Mutua de Terrassa, Terrassa
Parc de Salut Mar- Hospital del Mar, Barcelona
Hospital de la Santa Creu i Sant Pau, Barcelona
Hacettepe Universitesi Tip Fakultesi, Ankara
Ankara University Faculty of Medicine, Ankara
T.C. Saglik Bakanligi Ankara Sehir Hastanesi, Ankara
Kyivska miska klinichna likarnia No. 3, khirurhichne viddilennia, Kyiv
Kyivska miska klinichna likarnia #4, khirurhichne viddilennia #1, Kyiv
Lead Sponsor
Innovative Medicines Initiative
OTHER
Biomedical Advanced Research and Development Authority
FED
Pfizer
INDUSTRY