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



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:1 - 17
Updated:2/21/2019
Start Date:March 27, 2018
End Date:May 9, 2022
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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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)

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,


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
We found this trial at
21
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Phone: 718-741-2484
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Phone: 773-702-1665
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Phone: 513-636-7499
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Phone: 323-361-5047
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
Phone: 901-595-1475
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-322-2757
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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100 N Mario Capecchi Dr
Salt Lake City, Utah 84132
(801) 662-1000
Phone: 801-581-6631
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Phone: 720-777-8591
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Baltimore, Maryland 21287
Phone: 410-614-2949
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Baton Rouge, Louisiana 70808
Phone: 225-765-4365
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Boston, Massachusetts 02111
Phone: 617-636-0186
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Cali, Valle Del Cauca 760032
Phone: +573188372518
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Cleveland, Ohio 44012
Phone: 216-983-6925
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Durham, North Carolina
Phone: 919-668-4855
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New York, New York 10032
Phone: 212-342-3647
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Phone: 507-293-5841
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Saint Louis, Missouri 63110
Phone: 314-747-5128
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San Antonio, Texas 78207
Phone: 210-704-4708
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San Francisco, California 94115
Phone: 415-476-1756
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Phone: 206-884-5086
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Syracuse, New York 13210
Phone: 315-464-7353
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