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Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001) (MODIFY III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03182907
Recruitment Status : Completed
First Posted : June 9, 2017
Last Update Posted : September 27, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and tolerability of bezlotoxumab in children aged 1 to <18 years of age with a confirmed diagnosis of Clostridium difficile infection (CDI) who are receiving antibacterial drug treatment. The primary hypothesis is that the area under the concentration-time curve from 0 to infinity (AUC0-inf) of bezlotoxumab after treatment of pediatric participants with bezlotoxumab is similar when compared to the AUC0-inf of bezlotoxumab after treatment of adults with bezlotoxumab,

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Biological: Bezlotoxumab Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of a Single Infusion of Bezlotoxumab (MK-6072, Human Monoclonal Antibody to C. Difficile Toxin B) in Children Aged 1 to <18 Years Receiving Antibacterial Drug Treatment for C. Difficile Infection (MODIFY III)
Actual Study Start Date : March 27, 2018
Actual Primary Completion Date : May 12, 2022
Actual Study Completion Date : May 12, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Biological: 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.
Other Name: MK-6072
Placebo Comparator: Placebo
A single IV infusion of placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose
 Drug: Placebo
A single IV infusion of placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose.


Outcome Measures
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Primary Outcome Measures :
  1. Concentration time curve of bezlotoxumab [ Time Frame: Day 1 (2 hrs after infusion), Days 10, 29, 57, and 85 ]
    Area under the concentration time curve from time 0 to infinity (AUC0-inf) of serum bezlotoxumab

  2. Adverse events (AEs) [ Time Frame: Up to Day 90 ]
    Percentage of participants experiencing AEs

  3. Discontinuing medication [ Time Frame: Day 1 ]
    Percentage of participants discontinuing study medication due to an AE


Secondary Outcome Measures :
  1. Clostridium difficile infection (CDI) recurrence [ Time Frame: Up to Week 12 ]
    Percentage of participants who have a CDI recurrence within 12 weeks of study medication infusion.

  2. Sustained clinical response [ Time Frame: Up to Week 12 ]
    Percentage of participants with sustained clinical response within 12 weeks of study medication infusion.

  3. CDI recurrence and sustained clinical response [ Time Frame: Up to Week 12 ]
    Percentage of participants who have a CDI recurrence and who achieve sustained clinical response within 12 weeks of study medication infusion in participants at high risk of CDI recurrence.

  4. Infusion-related reactions [ Time Frame: Up to 24 hours ]
    Percentage of participants experiencing 1 or more infusion-related reactions within 24 hours following the start of study medication infusion.

  5. Positive antibodies to bezlotoxumab [ Time Frame: Up to Week 12 ]
    Percentage of participants with treatment-emergent positive antibodies to bezlotoxumab in serum through 12 weeks following a single dose of bezlotoxumab.


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At screening has suspected or confirmed CDI, and is receiving or is planning to receive a 10- to 21-day course of antibacterial drug treatment for CDI
  • 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 an uncontrolled chronic diarrheal illness
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182907


Locations
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United States, California
Children's Hospital - Los Angeles ( Site 0021)
Los Angeles, California, United States, 90027
UCSF Medical Center ( Site 0049)
San Francisco, California, United States, 94158
United States, Colorado
Children's Hospital - Colorado ( Site 0013)
Aurora, Colorado, United States, 80045
United States, Georgia
Children's Center for Digestive Healthcare ( Site 0052)
Atlanta, Georgia, United States, 30342
United States, Illinois
University of Chicago ( Site 0019)
Chicago, Illinois, United States, 60637
United States, Louisiana
Our Lady of the Lake Hospital ( Site 0007)
Baton Rouge, Louisiana, United States, 70808
United States, Maryland
The Johns Hopkins Rubenstein Child Health Building ( Site 0034)
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Tufts Medical Center-Floating Hospital for Children ( Site 0046)
Boston, Massachusetts, United States, 02111
United States, Minnesota
Mayo Clinic - Rochester ( Site 0004)
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University ( Site 0037)
Saint Louis, Missouri, United States, 63110
United States, New York
Montefiore Einstein Center ( Site 0041)
Bronx, New York, United States, 10467
Columbia University Medical Center/ MSCHONY ( Site 0042)
New York, New York, United States, 10032
SUNY Upstate Medical Center, University Hospital ( Site 0027)
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University Health System ( Site 0025)
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati Children's Hospital Medical Center ( Site 0024)
Cincinnati, Ohio, United States, 45229
University Hospitals Cleveland Medical Center ( Site 0029)
Cleveland, Ohio, United States, 44106
United States, Tennessee
St. Jude Children's Research Hospital ( Site 0050)
Memphis, Tennessee, United States, 38105
Vanderbilt University Medical Center ( Site 0022)
Nashville, Tennessee, United States, 37232
United States, Texas
The Children's Hospital of San Antonio ( Site 0009)
San Antonio, Texas, United States, 78207
United States, Utah
Primary Children's Hospital ( Site 0001)
Salt Lake City, Utah, United States, 84113
United States, Washington
Seattle Childrens Hospital ( Site 0028)
Seattle, Washington, United States, 98105
Argentina
Hospital Italiano de Buenos Aires. ( Site 2103)
Caba, Buenos Aires, Argentina, C1199ABB
Hospital Privado de Cordoba ( Site 2102)
Cordoba, Argentina, X5016KEH
Brazil
Santa Casa de Misericordia de Belo Horizonte ( Site 0208)
Belo Horizonte, Minas Gerais, Brazil, 30150-321
Hospital de Clinicas da Universidade Federal do Parana ( Site 0203)
Curitiba, Parana, Brazil, 80060-900
Hospital Pequeno Principe ( Site 0200)
Curitiba, Parana, Brazil, 80250-060
Hospital Universitario da Universidade Federal de Santa Maria ( Site 0209)
Santa Maria, Rio Grande Do Sul, Brazil, 97105-900
Instituto de Oncologia Pediatrica - GRAACC - Unifesp ( Site 0205)
Sao Paulo, Brazil, 04039-001
Colombia
Hospital Pablo Tobon Uribe-Infectology pediatric ( Site 2166)
Medellin, Antioquia, Colombia, 05034
Fundacion Cardioinfantil Instituto de Cardiologia ( Site 2163)
Bogota, Distrito Capital De Bogota, Colombia, 110131
Fundacion Santa Fe de Bogota ( Site 2167)
Bogotá, Distrito Capital De Bogota, Colombia, 110111
Fundacion Valle del Lili ( Site 2161)
Cali, Valle Del Cauca, Colombia, 760032
Centro Medico Imbanaco ( Site 2160)
Cali, Valle Del Cauca, Colombia, 760042
Czechia
Fakultni Nemocnice Brno Bohunice ( Site 2000)
Brno, Brno-mesto, Czechia, 61300
Fakultni nemocnice Plzen ( Site 2001)
Plzen Lochotin, Plzensky Kraj, Czechia, 304 60
2. LF UK a FN Motol ( Site 2003)
Praha 5, Czechia, 150 06
Germany
Universitaetsklinikum Muenster ( Site 1400)
Muenster, Nordrhein-Westfalen, Germany, 48149
Universitaetsklinikum Hamburg Eppendorf ( Site 1402)
Hamburg, Germany, 20246
Hungary
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 2200)
Szeged, Csongrad, Hungary, 6720
Semmelweis University-II.sz. Gyermekgyógyászati Klinika ( Site 2201)
Budapest, Hungary, 1094
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 2202)
Budapest, Hungary, 1097
Malaysia
Sabah Womens & Childrens Hospital ( Site 3101)
Kota Kinabalu, Sabah, Malaysia, 88996
Hospital Kuala Lumpur ( Site 3100)
Kuala Lumpur, Malaysia, 50300
Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0508)
Monterrey, Nuevo Leon, Mexico, 64400
Instituto Tecnologico y de Estudios Superiores de Monterrey ( Site 0502)
Monterrey, Nuevo Leon, Mexico, 64710
Instituto Nacional de Pediatria ( Site 0503)
Mexico City, Mexico, 04530
Hospital Infantil de Mexico Federico Gomez ( Site 0501)
Mexico City, Mexico, 06720
Norway
Haukeland universitetssykehus ( Site 1501)
Bergen, Vestfold, Norway, 5053
Oslo universitetssykehus ( Site 1500)
Oslo, Norway, 0372
Poland
Wojewodzki Szpital Obserwacyjno Zakazny ( Site 2404)
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-030
Wojewodzki Specjalistyczny Szpital im. dr W. Bieganskiego w Lodzi ( Site 2400)
Lodz, Lodzkie, Poland, 91-347
SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 2405)
Lomianki, Mazowieckie, Poland, 05-092
Instytut Pomnik Centrum Zdrowia Dziecka ( Site 2406)
Warszawa, Mazowieckie, Poland, 04-730
Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 2410)
Olsztyn, Warminsko-mazurskie, Poland, 10-561
Portugal
Hospital de Braga ( Site 1600)
Braga, Portugal, 4710-243
Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 1605)
Lisboa, Portugal, 1099-023
Centro Hospitalar de Lisboa Central EPE. Hospital D. Estefania ( Site 1601)
Lisboa, Portugal, 1169-045
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 1603)
Porto, Portugal, 4200-072
Romania
Spitalul Clinic de Boli Infectioase Cluj-Napoca ( Site 2502)
Cluj-Napoca, Cluj, Romania, 400348
Institutul National de Boli Infectioase Prof. Dr. Matei Bals ( Site 2501)
Bucuresti, Romania, 021105
Spitalul Clinic de Boli Infectioase si Tropicale Dr. Victor Babes ( Site 2500)
Bucuresti, Romania, 030303
Spitalul Clinic de Boli Infectioase Constanta ( Site 2504)
Constanta, Romania, 900708
South Africa
Phoenix Pharma Pty Ltd ( Site 2607)
Port Elizabeth, Eastern Cape, South Africa, 6001
Johese Clinical Research ( Site 2605)
Centurion, Gauteng, South Africa, 1692
Chris Hani Baragwanath Academic Hospital ( Site 2602)
Johannesburg, Gauteng, South Africa, 1860
Molotlegi Street ( Site 2603)
Pretoria, Gauteng, South Africa, 0208
Red Cross War Memorial Children's Hospital ( Site 2601)
Cape Town, Western Cape, South Africa, 7700
Spain
Hospital Universitario Sant Joan de Deu ( Site 1704)
Esplugues de Llobregat, Barcelona, Spain, 08950
Hospital Infantil Universitario Nino Jesus ( Site 1701)
Madrid, Spain, 28009
Hospital Universitario La Paz ( Site 1703)
Madrid, Spain, 28046
Hospital Universitario Virgen del Rocio ( Site 1705)
Sevilla, Spain, 41013
Sweden
ITCC Barnokologen Astrid Lindgrens Barnsjukhus NKS ( Site 1800)
Stockholm, Stockholms Lan, Sweden, 17176
Barncancercentrum ( Site 1801)
Goteborg, Vastra Gotalands Lan, Sweden, 416 85
United Kingdom
Southampton General Hospital ( Site 1900)
Southampton, Worcestershire, United Kingdom, SO16 6YD
Leeds Teaching Hospitals NHS Trust ( Site 1901)
Leeds, United Kingdom, LS1 3EX
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT03182907    
Other Study ID Numbers: 6072-001
2017-000070-11 ( EudraCT Number )
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: September 27, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Clostridium Infections
Disease Attributes
 Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses