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 |
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Recruitment Status :
Recruiting
First Posted : June 9, 2017
Last Update Posted : February 19, 2019
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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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 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
Drug Information available for:
Bezlotoxumab
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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Placebo Comparator: Placebo
A single IV infusion of placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose
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Drug: Placebo
A single IV infusion of placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose. |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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.
Information from the National Library of Medicine
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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 |
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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:
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Infection Communicable Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |