15
Participants
Start Date
December 25, 2020
Primary Completion Date
January 23, 2023
Study Completion Date
January 23, 2023
ATM-AVI
ATM-AVI doses (loading, extended loading and maintenance) and the dosing frequency of the maintenance dose are dependent on renal function. Subjects will be given a loading dose of 500 mg ATM plus 167 mg AVI or 675 mg ATM plus 225 mg AVI over a period of 30 minutes. This treatment will immediately be followed by an extended loading dose of 1500 mg ATM plus 500 mg AVI or 675 mg ATM plus 225 mg AVI over a period of 3 hours. Then there will be a 3 hour or 5 hour gap. Subjects will receive a maintenance dose of 1500 mg ATM plus 500 mg AVI every 6 hours or 750 mg ATM plus 250 mg AVI every 6 hours, or 675 mg ATM plus 225 mg AVI every 8 hours. Subjects with cIAI will also receive Metronidazole (MTZ) 500 mg IV q8h over 60 minutes. The first dose of MTZ will be started immediately after the extended loading dose of ATM-AVI has completed and treatment will be continued until the end of the treatment period.
BAT
The comparator treatment in this study is best available therapy (BAT) based upon site practice and local epidemiology. The choice of BAT (monotherapy or combination) for each subject must be recorded prior to randomization. If the chosen BAT does not provide adequate anaerobic coverage for cIAI subjects MTZ is to be administered as a co therapy. BAT dose, frequency, dose adjustments with renal impairment will be based on per local package inserts.
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City
Manila Doctors Hospital, Manila
St. Luke's Medical Center, Quezon City
Makati Medical Center, Makati City
Hospital San Roque, Córdoba
Davao Doctors Hospital, Davao City
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, Medicine and Infectious Diseases", Athens
Srinagarind Hospital, Division of lnfectious Disease and Tropical Medicine, Muang
University General Hospital of Larissa, Larissa
"Hospital Civil de Guadalajara Fray Antonio Alcalde", Guadalajara
Hospital Kuala Lumpur, Kuala Lumpur
University Malaya Medical Centre, Kuala Lumpur
University General Hospital of Heraklion, Heraklion, Crete
Kaohsiung Veterans General Hospital, Kaohsiung City
Banner University Medical Center Tucson, Tucson
Songklanagarind Hospital, Prince of Songkla University, Hat Yai
"SBHI of the city of Moscow N.I.Pirogov City Clinical Hospital # 1", Moscow
Huashan Hospital Fudan University, Shanghai
"OGBUZ Smolensk Regional Clinical Hospital", Smolensk
"FSBEI of HE Smolensk State Medical University of the Ministry of Health of the RF", Smolensk
SRI of Antimicrobial Chemotherapy, Smolensk
"Spitalul Clinic Judetean de Urgenta Pius Brinzeu", Timișoara
S.R.Kalla Memorial Gastro & General Hospital, Jaipur
Spitalul Clinic de Boli Infectioase Cluj Napoca, Cluj-Napoca
Hunan Province People's Hospital, Changsha
Deenanath Mangeshkar Hospital And Research Centre, Pune
The First Affiliated Hospital of Shantou University Medical College, Shantou
Victoria Hospital, Bangalore Medical College and Research Institute, Bangalore
Apollo Hospitals Enterprise Limited, Chennai
The First Hospital of Kunming, Kunming
Government medical College, Kozhikode
"Spitalul Clinic de Boli Infectioase Sf. Parascheva Iasi", Iași
Baotou Central Hospital, Baotou
The First Hospital of Kunming, Kunming
"Institutul National de Boli Infectioase Prof. Dr. Matei Bals", Bucharest
"Spitalul Clinic de Boli Infectioase si Tropicale Dr. Victor Babes", Bucharest