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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03182907
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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)
Estimated Enrollment : 192 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
Estimated Primary Completion Date : May 9, 2022
Estimated Study Completion Date : May 9, 2022

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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


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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United States, California
Children's Hospital - Los Angeles ( Site 0021) Recruiting
Los Angeles, California, United States, 90027
Contact: Study Coordinator    323-361-5047      
UCSF Medical Center ( Site 0049) Recruiting
San Francisco, California, United States, 94158
Contact: Study Coordinator    415-476-1756      
United States, Colorado
Children's Hospital - Colorado ( Site 0013) Completed
Aurora, Colorado, United States, 80045
United States, Illinois
University of Chicago ( Site 0019) Recruiting
Chicago, Illinois, United States, 60637
Contact: Study Coordinator    773-702-1665      
United States, Louisiana
Our Lady of the Lake Hospital ( Site 0007) Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Study Coordinator    225-765-4365      
United States, Maryland
The Johns Hopkins Rubenstein Child Health Building ( Site 0034) Recruiting
Baltimore, Maryland, United States, 21287
Contact: Study Coordinator    410-614-2949      
United States, Massachusetts
Tufts Medical Center-Floating Hospital for Children ( Site 0046) Recruiting
Boston, Massachusetts, United States, 02111
Contact: Study Coordinator    617-636-0186      
United States, Minnesota
Mayo Clinic - Rochester ( Site 0004) Completed
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University ( Site 0037) Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Study Coordinator    314-747-5128      
United States, New York
Montefiore Einstein Center ( Site 0041) Completed
Bronx, New York, United States, 10467
Columbia University Medical Center/ MSCHONY ( Site 0042) Recruiting
New York, New York, United States, 10032
Contact: Study Coordinator    212-342-3647      
SUNY Upstate Medical Center, University Hospital ( Site 0027) Completed
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University Health System ( Site 0025) Recruiting
Durham, North Carolina, United States, 27710
Contact: Study Coordinator    919-668-4855      
United States, Ohio
Cincinnati Children's Hospital Medical Center ( Site 0024) Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Study Coordinator    513-636-7499      
University Hospitals Cleveland Medical Center ( Site 0029) Recruiting
Cleveland, Ohio, United States, 44106
Contact: Study Coordinator    216-983-6925      
United States, Tennessee
St. Jude Children's Research Hospital ( Site 0050) Recruiting
Memphis, Tennessee, United States, 38105
Contact: Study Coordinator    901-595-1475      
Vanderbilt University Medical Center ( Site 0022) Recruiting
Nashville, Tennessee, United States, 37232
Contact: Study Coordinator    615-322-2757      
United States, Texas
The Children's Hospital of San Antonio ( Site 0009) Recruiting
San Antonio, Texas, United States, 78207
Contact: Study Coordinator    210-704-4708      
United States, Utah
Primary Children's Hospital ( Site 0001) Completed
Salt Lake City, Utah, United States, 84113
United States, Washington
Seattle Childrens Hospital ( Site 0028) Recruiting
Seattle, Washington, United States, 98105
Contact: Study Coordinator    206-884-5086      
Argentina
Hospital Italiano de Buenos Aires. ( Site 2103) Recruiting
Caba, Buenos Aires, Argentina, C1199ABB
Contact: Study Coordinator    +5491155688183      
Hospital Privado de Cordoba ( Site 2102) Recruiting
Cordoba, Argentina, X5016KEH
Contact: Study Coordinator    +543513101447      
Brazil
Santa Casa de Misericordia de Belo Horizonte ( Site 0208) Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30150-321
Contact: Study Coordinator    +553132388849      
Hospital de Clinicas da Universidade Federal do Parana ( Site 0203) Recruiting
Curitiba, Parana, Brazil, 80060-900
Contact: Study Coordinator    +554133607938      
Hospital Pequeno Principe ( Site 0200) Recruiting
Curitiba, Parana, Brazil, 80250-060
Contact: Study Coordinator    +554191993340      
Hospital Universitario da Universidade Federal de Santa Maria ( Site 0209) Recruiting
Santa Maria, Rio Grande Do Sul, Brazil, 97105-900
Contact: Study Coordinator    +5555981129912      
Instituto de Oncologia Pediatrica - GRAACC - Unifesp ( Site 0205) Recruiting
Sao Paulo, Brazil, 04039-001
Contact: Study Coordinator    +551150808592      
Colombia
Fundacion Valle del Lili ( Site 2161) Recruiting
Cali, Cauca, Colombia, 760032
Contact: Study Coordinator    +573188372518      
Fundacion Cardioinfantil Instituto de Cardiologia ( Site 2163) Recruiting
Bogota, Distrito Capital De Bogota, Colombia, 110131
Contact: Study Coordinator    +573157734008      
Centro Medico Imbanaco ( Site 2160) Recruiting
Cali, Valle Del Cauca, Colombia, 760042
Contact: Study Coordinator    +572518500014091      
Czechia
Fakultni nemocnice Brno ( Site 2000) Recruiting
Brno, Brno-mesto, Czechia, 613 00
Contact: Study Coordinator    +420532234126      
Fakultni nemocnice Plzen ( Site 2001) Recruiting
Plzen Lochotin, Plzensky Kraj, Czechia, 304 60
Contact: Study Coordinator    +420377104330      
2. LF UK a FN Motol ( Site 2003) Recruiting
Praha 5, Czechia, 150 06
Contact: Study Coordinator    +420224436420      
Germany
Universitaetsklinikum Muenster ( Site 1400) Recruiting
Muenster, Nordrhein-Westfalen, Germany, 48149
Contact: Study Coordinator    +492518352840      
Universitaetsklinikum Hamburg Eppendorf ( Site 1402) Recruiting
Hamburg, Germany, 20246
Contact: Study Coordinator    +4940741052720      
Hungary
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 2200) Recruiting
Szeged, Csongrad, Hungary, 6720
Contact: Study Coordinator    +3662545330      
Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika ( Site 2201) Recruiting
Budapest, Hungary, 1094
Contact: Study Coordinator    +3612151380      
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 2202) Recruiting
Budapest, Hungary, 1097
Contact: Study Coordinator    +3614558517      
Malaysia
Sabah Womens & Childrens Hospital ( Site 3101) Recruiting
Kota Kinabalu, Sabah, Malaysia, 88996
Contact: Study Coordinator    +6088522600      
Hospital Kuala Lumpur ( Site 3100) Recruiting
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 50300
Contact: Study Coordinator    +60326155555      
Mexico
Instituto Tecnologico y de Estudios Superiores de Monterrey ( Site 0502) Completed
Monterrey, Nuevo Leon, Mexico, 64710
Instituto Nacional de Pediatria ( Site 0503) Recruiting
Mexico City, Mexico, 04530
Contact: Study Coordinator    +525510840900      
Hospital Infantil de Mexico Federico Gomez ( Site 0501) Recruiting
Mexico City, Mexico, 06720
Contact: Study Coordinator    +525552289917      
Norway
Haukeland universitetssykehus ( Site 1501) Recruiting
Bergen, Vestfold, Norway, 5053
Contact: Study Coordinator    +4755975200      
Oslo universitetssykehus ( Site 1500) Recruiting
Oslo, Norway, 0372
Contact: Study Coordinator    +4723074593      
Poland
Wojewodzki Szpital Obserwacyjno Zakazny ( Site 2404) Recruiting
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-030
Contact: Study Coordinator    +48523255605      
Wojewodzki Specjalistyczny Szpital im. dr W. Bieganskiego w Lodzi ( Site 2400) Recruiting
Lodz, Lodzkie, Poland, 91-347
Contact: Study Coordinator    +48422516104      
SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 2405) Recruiting
Lomianki, Mazowieckie, Poland, 05-092
Contact: Study Coordinator    +48227657153      
Instytut Pomnik Centrum Zdrowia Dziecka ( Site 2406) Recruiting
Warszawa, Mazowieckie, Poland, 04-730
Contact: Study Coordinator    +48228157384      
Portugal
Hospital de Braga ( Site 1600) Recruiting
Braga, Portugal, 4710-243
Contact: Study Coordinator    +35125302724911010      
Centro Hospitalar de Lisboa Central EPE. Hospital D. Estefania ( Site 1601) Recruiting
Lisboa, Portugal, 1169-045
Contact: Study Coordinator    +351213126600      
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 1603) Recruiting
Porto, Portugal, 4200-072
Contact: Study Coordinator    +351225084000      
Romania
Spitalul Clinic de Boli Infectioase Cluj-Napoca ( Site 2502) Recruiting
Cluj-Napoca, Cluj, Romania, 400348
Contact: Study Coordinator    +40751519421      
Institutul National de Boli Infectioase Prof. Dr. Matei Bals ( Site 2501) Recruiting
Bucuresti, Romania, 021105
Contact: Study Coordinator    +40724354456      
Spitalul Clinic de Boli Infectioase si Tropicale Dr. Victor Babes ( Site 2500) Recruiting
Bucuresti, Romania, 030303
Contact: Study Coordinator    +40723577388      
Spitalul Clinic de Boli Infectioase Constanta ( Site 2504) Recruiting
Constanta, Romania, 900708
Contact: Study Coordinator    +40723472844      
South Africa
Phoenix Pharma Pty Ltd ( Site 2607) Recruiting
Port Elizabeth, Eastern Cape, South Africa, 6001
Contact: Study Coordinator    +27413733832      
Johese Clinical Research ( Site 2605) Recruiting
Centurion, Gauteng, South Africa, 1692
Contact: Study Coordinator    +27126641608      
Chris Hani Baragwanath Academic Hospital ( Site 2602) Recruiting
Johannesburg, Gauteng, South Africa, 1860
Contact: Study Coordinator    +27119330270      
Sefako Makgatho Health Sciences University ( Site 2603) Recruiting
Pretoria, Gauteng, South Africa, 0208
Contact: Study Coordinator    +27125215633      
Red Cross War Memorial Children's Hospital ( Site 2601) Recruiting
Cape Town, Western Cape, South Africa, 7700
Contact: Study Coordinator    +27216585369      
Spain
Hospital Universitario Sant Joan de Deu ( Site 1704) Recruiting
Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
Contact: Study Coordinator    +34915035900235      
Hospital Infantil Universitario Nino Jesus ( Site 1701) Recruiting
Madrid, Spain, 28009
Contact: Study Coordinator    +34915035900      
Hospital Universitario La Paz ( Site 1703) Recruiting
Madrid, Spain, 28046
Contact: Study Coordinator    +34915035900235      
Hospital Universitario Virgen del Rocio ( Site 1705) Recruiting
Sevilla, Spain, 41013
Contact: Study Coordinator    +34955012914      
Sweden
ITCC Barnokologen Astrid Lindgrens Barnsjukhus NKS ( Site 1800) Recruiting
Stockholm, Stockholms Lan [se-01], Sweden, 171 76
Contact: Study Coordinator    +46722214431      
Barncancercentrum ( Site 1801) Recruiting
Goteborg, Vastra Gotalands Lan [se-14], Sweden, 416 85
Contact: Study Coordinator    +46313436082      
United Kingdom
Southampton General Hospital ( Site 1900) Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Study Coordinator    +442381206883      
Leeds Teaching Hospitals NHS Trust ( Site 1901) Recruiting
Leeds, United Kingdom, LS1 3EX
Contact: Study Coordinator    +447824519571      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information
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Responsible Party: Merck Sharp & Dohme Corp.
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: May 8, 2020
Last Verified: May 2020
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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Infection
Communicable Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections