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

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ClinicalTrials.gov Identifier: NCT03182907
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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 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

Resource links provided by the National Library of Medicine


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.




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.



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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

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

  Hide Study Locations
Locations
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) Recruiting
Aurora, Colorado, United States, 80045
Contact: Study Coordinator    720-777-8591      
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) Recruiting
Rochester, Minnesota, United States, 55905
Contact: Study Coordinator    507-293-5841      
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 Medical Center ( Site 0041) Recruiting
Bronx, New York, United States, 10467
Contact: Study Coordinator    718-741-2484      
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) Recruiting
Syracuse, New York, United States, 13210
Contact: Study Coordinator    315-464-7353      
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 Medical Center ( Site 0001) Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Study Coordinator    801-581-6631      
United States, Washington
Seattle Childrens Hospital ( Site 0028) Recruiting
Seattle, Washington, United States, 98105
Contact: Study Coordinator    206-884-5086      
Colombia
Fundacion Valle del Lili ( Site 2161) Recruiting
Cali, Valle Del Cauca, Colombia, 760032
Contact: Study Coordinator    +573188372518      
Centro Medico Imbanaco ( Site 2160) Recruiting
Cali, Colombia, 760042
Contact: Study Coordinator    +572518500014091      
Czechia
Fakultni nemocnice Brno ( Site 2000) Recruiting
Brno, Czechia, 613 00
Contact: Study Coordinator    +420532234126      
Fakultni nemocnice Plzen ( Site 2001) Recruiting
Plzen Lochotin, Czechia, 304 60
Contact: Study Coordinator    +420377104330      
2. LF UK a FN Motol ( Site 2003) Recruiting
Praha 5, Czechia, 150 06
Contact: Study Coordinator    +420224436568      
Hungary
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      
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 2200) Recruiting
Szeged, Hungary, 6720
Contact: Study Coordinator    +3662545330      
Mexico
Instituto Tecnologico y de Estudios Superiores de Monterrey ( Site 0502) Recruiting
Monterrey, Nuevo Leon, Mexico, 64710
Contact: Study Coordinator    +528188882140      
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, 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, Poland, 85-030
Contact: Study Coordinator    +48523255605      
Wojewodzki Specjalistyczny Szpital im. dr W. Bieganskiego w Lodzi ( Site 2400) Recruiting
Lodz, Poland, 91-347
Contact: Study Coordinator    +48422516104      
SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 2405) Recruiting
Lomianki, Poland, 05-092
Contact: Study Coordinator    +48227657153      
Instytut Pomnik Centrum Zdrowia Dziecka ( Site 2406) Recruiting
Warszawa, Poland, 04-730
Contact: Study Coordinator    +48228157384      
Portugal
Centro Hospitalar de Lisboa Central EPE. Hospital D. Estefania ( Site 1601) Recruiting
Lisboa, Portugal, 1169-045
Contact: Study Coordinator    +351916149491      
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 1603) Recruiting
Porto, Portugal, 4200-072
Contact: Study Coordinator    +351225084000      
South Africa
Johese Clinical Research ( Site 2605) Recruiting
Centurion, South Africa, 1692
Contact: Study Coordinator    +27126641608      
Chris Hani Baragwanath Academic Hospital ( Site 2602) Recruiting
Johannesburg, South Africa, 1860
Contact: Study Coordinator    +27119330270      
Sefako Makgatho Health Sciences University ( Site 2603) Recruiting
Pretoria, South Africa, 0208
Contact: Study Coordinator    +27125215633      
Spain
Hospital Universitario Sant Joan de Deu ( Site 1704) Recruiting
Esplugues de Llobregat, Spain, 08950
Contact: Study Coordinator    +34915035900235      
Hospital Infantil Universitario Nino Jesus ( Site 1701) Recruiting
Madrid, Spain, 28009
Contact: Study Coordinator    +34915035900235      
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    +34955013704      
Sweden
Barncancercentrum ( Site 1801) Recruiting
Goteborg, Sweden, 416 85
Contact: Study Coordinator    +46313436082      
ITCC Barnokologen Astrid Lindgrens Barnsjukhus NKS ( Site 1800) Recruiting
Stockholm, Sweden, 171 76
Contact: Study Coordinator    +46722214431      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03182907     History of Changes
Other Study ID Numbers: 6072-001
2017-000070-11 ( EudraCT Number )
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
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

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs