148
Participants
Start Date
March 27, 2018
Primary Completion Date
May 12, 2022
Study Completion Date
May 12, 2022
Bezlotoxumab
A single intravenous (IV) infusion of 10 mg of bezlotoxumab per kg body weight. Dose may then be changed based on results from initial 12 participants.
Placebo
A single IV infusion of placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose.
Antibacterial drug treatment (ABD)
ABD will be administered for 10-21 days including the duration of ABD prior to the screening visit, during the screening period, and after the infusion of study treatment, per institutional guidelines, at the investigator's discretion. ABD is defined as the receipt of oral metronidazole, oral vancomycin, intravenous (IV) metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole.
Semmelweis University-II.sz. Gyermekgyógyászati Klinika ( Site 2201), Budapest
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 2202), Budapest
Johese Clinical Research ( Site 2605), Centurion
Chris Hani Baragwanath Academic Hospital ( Site 2602), Johannesburg
Haukeland universitetssykehus ( Site 1501), Bergen
Phoenix Pharma Pty Ltd ( Site 2607), Port Elizabeth
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 2200), Szeged
Red Cross War Memorial Children's Hospital ( Site 2601), Cape Town
Columbia University Medical Center/ MSCHONY ( Site 0042), New York
Montefiore Einstein Center ( Site 0041), The Bronx
SUNY Upstate Medical Center, University Hospital ( Site 0027), Syracuse
ITCC Barnokologen Astrid Lindgrens Barnsjukhus NKS ( Site 1800), Stockholm
Universitaetsklinikum Hamburg Eppendorf ( Site 1402), Hamburg
The Johns Hopkins Rubenstein Child Health Building ( Site 0034), Baltimore
Duke University Health System ( Site 0025), Durham
Hospital Infantil Universitario Nino Jesus ( Site 1701), Madrid
Hospital Universitario La Paz ( Site 1703), Madrid
Children's Center for Digestive Healthcare ( Site 0052), Atlanta
Vanderbilt University Medical Center ( Site 0022), Nashville
St. Jude Children's Research Hospital ( Site 0050), Memphis
Hospital Universitario Virgen del Rocio ( Site 1705), Seville
University Hospitals Cleveland Medical Center ( Site 0029), Cleveland
Cincinnati Children's Hospital Medical Center ( Site 0024), Cincinnati
Universitaetsklinikum Muenster ( Site 1400), Münster
Hospital Kuala Lumpur ( Site 3100), Kuala Lumpur
Mayo Clinic - Rochester ( Site 0004), Rochester
University of Chicago ( Site 0019), Chicago
Fakultni Nemocnice Brno Bohunice ( Site 2000), Brno
Washington University ( Site 0037), St Louis
"Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0508)", Monterrey
Instituto Tecnologico y de Estudios Superiores de Monterrey ( Site 0502), Monterrey
Our Lady of the Lake Hospital ( Site 0007), Baton Rouge
The Children's Hospital of San Antonio ( Site 0009), San Antonio
Children's Hospital - Colorado ( Site 0013), Aurora
Primary Children's Hospital ( Site 0001), Salt Lake City
Sabah Womens & Childrens Hospital ( Site 3101), Kota Kinabalu
Children's Hospital - Los Angeles ( Site 0021), Los Angeles
UCSF Medical Center ( Site 0049), San Francisco
Seattle Childrens Hospital ( Site 0028), Seattle
Fundacion Santa Fe de Bogota ( Site 2167), Bogotá
Fundacion Cardioinfantil Instituto de Cardiologia ( Site 2163), Bogotá
Spitalul Clinic de Boli Infectioase Cluj-Napoca ( Site 2502), Cluj-Napoca
Fundacion Valle del Lili ( Site 2161), Santiago de Cali
Centro Medico Imbanaco ( Site 2160), Santiago de Cali
Spitalul Clinic de Boli Infectioase Constanta ( Site 2504), Constanța
Tufts Medical Center-Floating Hospital for Children ( Site 0046), Boston
Hospital Italiano de Buenos Aires. ( Site 2103), Caba
Hospital Privado de Cordoba ( Site 2102), Córdoba
Santa Casa de Misericordia de Belo Horizonte ( Site 0208), Belo Horizonte
Hospital de Clinicas da Universidade Federal do Parana ( Site 0203), Curitiba
Hospital Pequeno Principe ( Site 0200), Curitiba
Hospital Universitario da Universidade Federal de Santa Maria ( Site 0209), Santa Maria
Instituto de Oncologia Pediatrica - GRAACC - Unifesp ( Site 0205), São Paulo
Hospital Pablo Tobon Uribe-Infectology pediatric ( Site 2166), Medellín
Fakultni nemocnice Plzen ( Site 2001), Plzen Lochotin
2. LF UK a FN Motol ( Site 2003), Prague
Instituto Nacional de Pediatria ( Site 0503), Mexico City
Hospital Infantil de Mexico Federico Gomez ( Site 0501), Mexico City
Oslo universitetssykehus ( Site 1500), Oslo
Wojewodzki Szpital Obserwacyjno Zakazny ( Site 2404), Bydgoszcz
Instytut Pomnik Centrum Zdrowia Dziecka ( Site 2406), Warsaw
SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 2405), Łomianki
Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 2410), Olsztyn
Wojewodzki Specjalistyczny Szpital im. dr W. Bieganskiego w Lodzi ( Site 2400), Lodz
Hospital de Braga ( Site 1600), Braga
Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 1605), Lisbon
Centro Hospitalar de Lisboa Central EPE. Hospital D. Estefania ( Site 1601), Lisbon
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 1603), Porto
Institutul National de Boli Infectioase Prof. Dr. Matei Bals ( Site 2501), Bucharest
Spitalul Clinic de Boli Infectioase si Tropicale Dr. Victor Babes ( Site 2500), Bucharest
Molotlegi Street ( Site 2603), Pretoria
Hospital Universitario Sant Joan de Deu ( Site 1704), Esplugues de Llobregat
Barncancercentrum ( Site 1801), Gothenburg
Southampton General Hospital ( Site 1900), Southampton
Leeds Teaching Hospitals NHS Trust ( Site 1901), Leeds
Merck Sharp & Dohme LLC
INDUSTRY