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 : May 31, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Clostridium Difficile Infection | Biological: Bezlotoxumab Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 143 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 |

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. |
- 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
- Adverse events (AEs) [ Time Frame: Up to Day 90 ]Percentage of participants experiencing AEs
- Discontinuing medication [ Time Frame: Day 1 ]Percentage of participants discontinuing study medication due to an AE
- 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.
- Sustained clinical response [ Time Frame: Up to Week 12 ]Percentage of participants with sustained clinical response within 12 weeks of study medication infusion.
- 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.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 1 Year to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Study Director: | Medical Director | Merck Sharp & Dohme LLC |
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: | May 31, 2022 |
Last Verified: | May 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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Infections Communicable Diseases Clostridium Infections Disease Attributes |
Pathologic Processes Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses |