115
Participants
Start Date
October 8, 2019
Primary Completion Date
May 7, 2024
Study Completion Date
May 7, 2024
IMI/REL
"Age-based dosing:~* 12 to \<18 years, IMI 500 and REL 250 mg, IV infusion every 6 hours~* 6 to \<12 years, IMI 15 and REL 7.5 mg/kg, IV infusion every 6 hours~* 2 to \<6 years, IMI 15 and REL 7.5 mg/kg, IV infusion every 6 hours~* 3 months to \<2 years, IMI 15 and REL 7.5 mg/kg, IV infusion every 6 hours~* Birth to \<3 months, IMI 15 and REL 7.5 mg/kg, IV infusion every 8 hours NOTE: Participants with cIAI or cUTI may be switched to oral therapy after at least 3 days of IV study intervention."
Active Control
"All active control medications will be chosen from a list of acceptable approved agents for each infection type (HABP or VABP, cIAI, and UTI) and will be given via IV infusion, per authorized Package Insert (PI), Summary of Product Characteristics (SPC), or international treatment guidelines.~NOTE: Participants with cIAI or cUTI may be switched to oral therapy after at least 3 days of IV study intervention. All oral switch medications will be chosen from a list of acceptable approved agents."
Oral Switch
All oral switch medications will be investigator's choice from a list of acceptable approved agents for infection types cIAI, and cUTI and will be given per authorized Package Insert (PI), Summary of Product Characteristics (SPC), or international treatment guidelines. Participants with cIAI or cUTI may be switched to oral therapy after at least 3 days of IV study intervention.
University of the Philippines-Philippine General Hospital ( Site 0318), Manila
Philippine Children s Medical Center ( Site 0317), Quezon City
Empilweni Services and Research Unit ( Site 1557), Johannesburg
Chris Hani Baragwanath Academic Hospital ( Site 0156), Johannesburg
MHAT City Clinic Sv. Georgi EOOD ( Site 0167), Montana
Debreceni Egyetem Klinikai Kozpont ( Site 0100), Debrecen
Szabolcs-Szatmar-Bereg Megyei Kórházak és Egyetemi Otatókórház-Gyermekosztály ( Site 0105), Nyíregyháza
Haukeland Universitetssjukehus ( Site 0500), Bergen
UMHAT Dr. Georgi Stranski EAD ( Site 0174), Pleven
UMHAT Kanev AD ( Site 0168), Rousse
UMHAT Kanev AD ( Site 0169), Rousse
UMHAT Deva Maria. EOOD ( Site 0165), Burgas
MHAT Dr. Ival Seliminski ( Site 0173), Sliven
Pan and Aglaia Kyriakou Children s Hospital ( Site 0247), Athens
Tallinn Children Hospital ( Site 0209), Tallinn
Centenario Hospital Miguel Hidalgo-Pediatrics Department ( Site 0290), Aguascalientes
Hopital Francois Mitterand ( Site 0146), Dijon
Hospital General de Tijuana ( Site 0284), Tijuana
Children's Hospital of Richmond at VCU ( Site 0359), Richmond
Eskisehir Osmangazi University Medical ( Site 0201), Eskişehir
West Virginia University Ruby Memorial Hospital ( Site 0344), Morgantown
Hospital Infantil Universitario Nino Jesus ( Site 0114), Madrid
Hospital Universitario La Paz ( Site 0113), Madrid
SBU Sariyer Hamidiye Etfal Egitim ve Arastirma Hastanesi ( Site 0198), Istanbul
Ege Universitesi Tıp Fakultesi Hastanesi ( Site 0199), Izmir
Municipal Enterprise Children's City Clinical Hospital in Poltava City Council ( Site 0122), Poltava
Hospital Universitario Virgen del Rocio ( Site 0115), Seville
SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 0121), Dnipro
"Communal non-commercial enterprise Kryvorizka city clinical hospital 16 of Kryvyy Rig city council", Kryvyy Rig
Hopital Jeanne de Flandre ( Site 0145), Lille
Kharkiv City Children Hospital 16 ( Site 0130), Kharkiv
Hospital del Nino y Adolescente Morelense ( Site 0286), Emiliano Zapata
Ivano-Frankivsk Regional Children Clinical Hospital ( Site 0131), Ivano-Frankivsk
University Hospital ( Site 0360), San Antonio
Banner University Medical Center ( Site 0356), Tucson
University of New Mexico ( Site 0358), Albuquerque
Miller Children's & Women's Hospital ( Site 0349), Long Beach
Rady Children's Hospital-San Diego ( Site 0347), San Diego
Fundacion Hospital Infantil Universitario de San Jose ( Site 0268), Bogotá
Pediatric Hematology Oncology and Immunology Centre n.a. D.Rogachev. ( Site 0233), Moscow
Morozovskaya Children City Clinical Hospital ( Site 0241), Moscow
Regional Childrens Clinical Hospital ( Site 0400), Vologda
Children s City Clinical Hospital 5 n.a. N.F. Filatov ( Site 0235), Saint Petersburg
St.Petersburg State Pediatric Medical University ( Site 0236), Saint Petersburg
Children's City Clinical Hospital #1 ( Site 0237), Saint Petersburg
Smolensk Regional Clinical Hospital ( Site 0231), Smolensk
State Budgetary Healthcare Institution of Novosibirsk Region City Childrens Clinical Emergency Hospi, Novosibirsk
Fundacion Valle del Lili ( Site 0266), Santiago de Cali
Rambam Medical Center ( Site 0189), Haifa
Schneider Children's Medical Center ( Site 0187), Petah Tikva
Chaim Sheba Medical Center ( Site 0190), Ramat Gan
Hospital Roberto del Río ( Site 0802), Santiago
Hadassah Ein Karem Hebrew University Medical Center ( Site 0188), Jerusalem
Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0265), Bogotá
Tufts Medical Center-Floating Hospital for Children ( Site 0350), Boston
Fundacion Hospital San Vicente de Paul ( Site 0269), Medellín
Clinica de la Costa S.A.S. ( Site 0264), Barranquilla
Hopitaux Pediatriques CHU Lenval ( Site 0143), Nice
University of Athens - Aghia Sophia Childrens Hospital ( Site 0243), Athens
Hippokration General Hospital of Thessaloniki ( Site 0244), Thessaloniki
Instituto Nacional de Pediatria ( Site 0291), Mexico City
Wojewodzki Szpital Zespolony im. Rydgiera ( Site 0220), Torun
SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0226), Łomianki
Instytut Centrum Zdrowia Matki Polki ( Site 0223), Lodz
Molotlegi Street ( Site 0155), Pretoria
Cukurova University Medical Faculty ( Site 0200), Adana
Ankara Universitesi Tip Fakultesi. ( Site 0202), Ankara
Merck Sharp & Dohme LLC
INDUSTRY