Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)
NCT ID: NCT03182907
Last Updated: 2023-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
148 participants
INTERVENTIONAL
2018-03-27
2022-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Bezlotoxumab
Participants receive 10 mg of bezlotoxumab per kg body weight via a single 60-minute (±10 minutes) intravenous (IV) infusion on Day 1. Additionally, participants receive background antibacterial drug treatment (ABD) for 10-21 days per institutional guidelines, at the investigator's discretion. Dose may then be changed based on results from initial 12 participants.
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.
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.
Placebo
Participants receive placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose via a single 60-minute (±10 minutes) IV infusion on Day 1. Additionally, participants receive background ABD for 10-21 days per institutional guidelines, at the investigator's discretion.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At study infusion has a diagnosis of CDI confirmed by a diagnostic assay which detects the presence of C. difficile toxin in stool, and is still receiving antibacterial drug treatment for CDI
* Female is not pregnant, and not breastfeeding; but if of childbearing potential agrees to follow contraceptive guidance during the treatment period and for at least 12 weeks after the last dose of study treatment
* Participant and/or parent or caregiver must be able to read, understand, and complete the daily diary
Exclusion Criteria
* Has a known hypersensitivity to bezlotoxumab, its active substance and/or any of its excipients
* At randomization, their planned course of antibacterial drug treatment for CDI is longer than 21 days
* At screening has received any listed prohibited prior and concomitant treatments and procedures
* Has previously participated in this study, has previously received bezlotoxumab, has received an experimental monoclonal antibody against C. difficile toxin B, or has received a vaccine directed against C. difficile or its toxins.
* Has received an investigational study agent within the previous 30 days, or is currently participating in or scheduled to participate in any other clinical study with an investigational agent during the 12-week study period
1 Year
17 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Children's Hospital - Los Angeles ( Site 0021)
Los Angeles, California, United States
UCSF Medical Center ( Site 0049)
San Francisco, California, United States
Children's Hospital - Colorado ( Site 0013)
Aurora, Colorado, United States
Children's Center for Digestive Healthcare ( Site 0052)
Atlanta, Georgia, United States
University of Chicago ( Site 0019)
Chicago, Illinois, United States
Our Lady of the Lake Hospital ( Site 0007)
Baton Rouge, Louisiana, United States
The Johns Hopkins Rubenstein Child Health Building ( Site 0034)
Baltimore, Maryland, United States
Tufts Medical Center-Floating Hospital for Children ( Site 0046)
Boston, Massachusetts, United States
Mayo Clinic - Rochester ( Site 0004)
Rochester, Minnesota, United States
Washington University ( Site 0037)
St Louis, Missouri, United States
Columbia University Medical Center/ MSCHONY ( Site 0042)
New York, New York, United States
SUNY Upstate Medical Center, University Hospital ( Site 0027)
Syracuse, New York, United States
Montefiore Einstein Center ( Site 0041)
The Bronx, New York, United States
Duke University Health System ( Site 0025)
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center ( Site 0024)
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center ( Site 0029)
Cleveland, Ohio, United States
St. Jude Children's Research Hospital ( Site 0050)
Memphis, Tennessee, United States
Vanderbilt University Medical Center ( Site 0022)
Nashville, Tennessee, United States
The Children's Hospital of San Antonio ( Site 0009)
San Antonio, Texas, United States
Primary Children's Hospital ( Site 0001)
Salt Lake City, Utah, United States
Seattle Childrens Hospital ( Site 0028)
Seattle, Washington, United States
Hospital Italiano de Buenos Aires. ( Site 2103)
Caba, Buenos Aires, Argentina
Hospital Privado de Cordoba ( Site 2102)
Córdoba, , Argentina
Santa Casa de Misericordia de Belo Horizonte ( Site 0208)
Belo Horizonte, Minas Gerais, Brazil
Hospital de Clinicas da Universidade Federal do Parana ( Site 0203)
Curitiba, Paraná, Brazil
Hospital Pequeno Principe ( Site 0200)
Curitiba, Paraná, Brazil
Hospital Universitario da Universidade Federal de Santa Maria ( Site 0209)
Santa Maria, Rio Grande do Sul, Brazil
Instituto de Oncologia Pediatrica - GRAACC - Unifesp ( Site 0205)
São Paulo, , Brazil
Hospital Pablo Tobon Uribe-Infectology pediatric ( Site 2166)
Medellín, Antioquia, Colombia
Fundacion Santa Fe de Bogota ( Site 2167)
Bogotá, Bogota D.C., Colombia
Fundacion Cardioinfantil Instituto de Cardiologia ( Site 2163)
Bogotá, Bogota D.C., Colombia
Fundacion Valle del Lili ( Site 2161)
Cali, Valle del Cauca Department, Colombia
Centro Medico Imbanaco ( Site 2160)
Cali, Valle del Cauca Department, Colombia
Fakultni Nemocnice Brno Bohunice ( Site 2000)
Brno, Brno-mesto, Czechia
Fakultni nemocnice Plzen ( Site 2001)
Plzen Lochotin, Plzeň Region, Czechia
2. LF UK a FN Motol ( Site 2003)
Prague, , Czechia
Universitaetsklinikum Muenster ( Site 1400)
Münster, North Rhine-Westphalia, Germany
Universitaetsklinikum Hamburg Eppendorf ( Site 1402)
Hamburg, , Germany
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 2200)
Szeged, Csongrád megye, Hungary
Semmelweis University-II.sz. Gyermekgyógyászati Klinika ( Site 2201)
Budapest, , Hungary
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 2202)
Budapest, , Hungary
Sabah Womens & Childrens Hospital ( Site 3101)
Kota Kinabalu, Sabah, Malaysia
Hospital Kuala Lumpur ( Site 3100)
Kuala Lumpur, , Malaysia
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0508)
Monterrey, Nuevo León, Mexico
Instituto Tecnologico y de Estudios Superiores de Monterrey ( Site 0502)
Monterrey, Nuevo León, Mexico
Instituto Nacional de Pediatria ( Site 0503)
Mexico City, , Mexico
Hospital Infantil de Mexico Federico Gomez ( Site 0501)
Mexico City, , Mexico
Haukeland universitetssykehus ( Site 1501)
Bergen, Vestfold, Norway
Oslo universitetssykehus ( Site 1500)
Oslo, , Norway
Wojewodzki Szpital Obserwacyjno Zakazny ( Site 2404)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Instytut Pomnik Centrum Zdrowia Dziecka ( Site 2406)
Warsaw, Masovian Voivodeship, Poland
SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 2405)
Łomianki, Masovian Voivodeship, Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 2410)
Olsztyn, Warmian-Masurian Voivodeship, Poland
Wojewodzki Specjalistyczny Szpital im. dr W. Bieganskiego w Lodzi ( Site 2400)
Lodz, Łódź Voivodeship, Poland
Hospital de Braga ( Site 1600)
Braga, , Portugal
Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 1605)
Lisbon, , Portugal
Centro Hospitalar de Lisboa Central EPE. Hospital D. Estefania ( Site 1601)
Lisbon, , Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 1603)
Porto, , Portugal
Spitalul Clinic de Boli Infectioase Cluj-Napoca ( Site 2502)
Cluj-Napoca, Cluj, Romania
Institutul National de Boli Infectioase Prof. Dr. Matei Bals ( Site 2501)
Bucharest, , Romania
Spitalul Clinic de Boli Infectioase si Tropicale Dr. Victor Babes ( Site 2500)
Bucharest, , Romania
Spitalul Clinic de Boli Infectioase Constanta ( Site 2504)
Constanța, , Romania
Phoenix Pharma Pty Ltd ( Site 2607)
Port Elizabeth, Eastern Cape, South Africa
Johese Clinical Research ( Site 2605)
Centurion, Gauteng, South Africa
Chris Hani Baragwanath Academic Hospital ( Site 2602)
Johannesburg, Gauteng, South Africa
Molotlegi Street ( Site 2603)
Pretoria, Gauteng, South Africa
Red Cross War Memorial Children's Hospital ( Site 2601)
Cape Town, Western Cape, South Africa
Hospital Universitario Sant Joan de Deu ( Site 1704)
Esplugues de Llobregat, Barcelona, Spain
Hospital Infantil Universitario Nino Jesus ( Site 1701)
Madrid, , Spain
Hospital Universitario La Paz ( Site 1703)
Madrid, , Spain
Hospital Universitario Virgen del Rocio ( Site 1705)
Seville, , Spain
ITCC Barnokologen Astrid Lindgrens Barnsjukhus NKS ( Site 1800)
Stockholm, Stockholm County, Sweden
Barncancercentrum ( Site 1801)
Gothenburg, Västra Götaland County, Sweden
Southampton General Hospital ( Site 1900)
Southampton, Worcestershire, United Kingdom
Leeds Teaching Hospitals NHS Trust ( Site 1901)
Leeds, , United Kingdom
Countries
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References
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Sferra TJ, Merta T, Neely M, Murta de Oliveira C, Lassaletta A, Fortuny Guasch C, Dorr MB, Winchell G, Su FH, Perko S, Fernsler D, Waskin H, Holden SR. Double-Blind, Placebo-Controlled Study of Bezlotoxumab in Children Receiving Antibacterial Treatment for Clostridioides difficile Infection (MODIFY III). J Pediatric Infect Dis Soc. 2023 Jun 30;12(6):334-341. doi: 10.1093/jpids/piad031.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trial Information
Other Identifiers
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MK-6072-001
Identifier Type: OTHER
Identifier Source: secondary_id
2017-000070-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
6072-001
Identifier Type: -
Identifier Source: org_study_id
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