search
Back to results

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

Primary Purpose

Clostridium Difficile Infection

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bezlotoxumab
Placebo
Antibacterial drug treatment (ABD)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridium Difficile Infection

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital - Los Angeles ( Site 0021)
  • UCSF Medical Center ( Site 0049)
  • Children's Hospital - Colorado ( Site 0013)
  • Children's Center for Digestive Healthcare ( Site 0052)
  • University of Chicago ( Site 0019)
  • Our Lady of the Lake Hospital ( Site 0007)
  • The Johns Hopkins Rubenstein Child Health Building ( Site 0034)
  • Tufts Medical Center-Floating Hospital for Children ( Site 0046)
  • Mayo Clinic - Rochester ( Site 0004)
  • Washington University ( Site 0037)
  • Montefiore Einstein Center ( Site 0041)
  • Columbia University Medical Center/ MSCHONY ( Site 0042)
  • SUNY Upstate Medical Center, University Hospital ( Site 0027)
  • Duke University Health System ( Site 0025)
  • Cincinnati Children's Hospital Medical Center ( Site 0024)
  • University Hospitals Cleveland Medical Center ( Site 0029)
  • St. Jude Children's Research Hospital ( Site 0050)
  • Vanderbilt University Medical Center ( Site 0022)
  • The Children's Hospital of San Antonio ( Site 0009)
  • Primary Children's Hospital ( Site 0001)
  • Seattle Childrens Hospital ( Site 0028)
  • Hospital Italiano de Buenos Aires. ( Site 2103)
  • Hospital Privado de Cordoba ( Site 2102)
  • Santa Casa de Misericordia de Belo Horizonte ( Site 0208)
  • Hospital de Clinicas da Universidade Federal do Parana ( Site 0203)
  • Hospital Pequeno Principe ( Site 0200)
  • Hospital Universitario da Universidade Federal de Santa Maria ( Site 0209)
  • Instituto de Oncologia Pediatrica - GRAACC - Unifesp ( Site 0205)
  • Hospital Pablo Tobon Uribe-Infectology pediatric ( Site 2166)
  • Fundacion Cardioinfantil Instituto de Cardiologia ( Site 2163)
  • Fundacion Santa Fe de Bogota ( Site 2167)
  • Fundacion Valle del Lili ( Site 2161)
  • Centro Medico Imbanaco ( Site 2160)
  • Fakultni Nemocnice Brno Bohunice ( Site 2000)
  • Fakultni nemocnice Plzen ( Site 2001)
  • 2. LF UK a FN Motol ( Site 2003)
  • Universitaetsklinikum Muenster ( Site 1400)
  • Universitaetsklinikum Hamburg Eppendorf ( Site 1402)
  • SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 2200)
  • Semmelweis University-II.sz. Gyermekgyógyászati Klinika ( Site 2201)
  • Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 2202)
  • Sabah Womens & Childrens Hospital ( Site 3101)
  • Hospital Kuala Lumpur ( Site 3100)
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0508)
  • Instituto Tecnologico y de Estudios Superiores de Monterrey ( Site 0502)
  • Instituto Nacional de Pediatria ( Site 0503)
  • Hospital Infantil de Mexico Federico Gomez ( Site 0501)
  • Haukeland universitetssykehus ( Site 1501)
  • Oslo universitetssykehus ( Site 1500)
  • Wojewodzki Szpital Obserwacyjno Zakazny ( Site 2404)
  • Wojewodzki Specjalistyczny Szpital im. dr W. Bieganskiego w Lodzi ( Site 2400)
  • SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 2405)
  • Instytut Pomnik Centrum Zdrowia Dziecka ( Site 2406)
  • Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 2410)
  • Hospital de Braga ( Site 1600)
  • Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 1605)
  • Centro Hospitalar de Lisboa Central EPE. Hospital D. Estefania ( Site 1601)
  • Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 1603)
  • Spitalul Clinic de Boli Infectioase Cluj-Napoca ( Site 2502)
  • Institutul National de Boli Infectioase Prof. Dr. Matei Bals ( Site 2501)
  • Spitalul Clinic de Boli Infectioase si Tropicale Dr. Victor Babes ( Site 2500)
  • Spitalul Clinic de Boli Infectioase Constanta ( Site 2504)
  • Phoenix Pharma Pty Ltd ( Site 2607)
  • Johese Clinical Research ( Site 2605)
  • Chris Hani Baragwanath Academic Hospital ( Site 2602)
  • Molotlegi Street ( Site 2603)
  • Red Cross War Memorial Children's Hospital ( Site 2601)
  • Hospital Universitario Sant Joan de Deu ( Site 1704)
  • Hospital Infantil Universitario Nino Jesus ( Site 1701)
  • Hospital Universitario La Paz ( Site 1703)
  • Hospital Universitario Virgen del Rocio ( Site 1705)
  • ITCC Barnokologen Astrid Lindgrens Barnsjukhus NKS ( Site 1800)
  • Barncancercentrum ( Site 1801)
  • Southampton General Hospital ( Site 1900)
  • Leeds Teaching Hospitals NHS Trust ( Site 1901)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bezlotoxumab

Placebo

Arm Description

Participants receive 10 mg of bezlotoxumab per kg body weight via a single 60-minute (±10 minutes) intravenous (IV) infusion on Day 1. Additionally, participants receive background antibacterial drug treatment (ABD) for 10-21 days per institutional guidelines, at the investigator's discretion. Dose may then be changed based on results from initial 12 participants.

Participants receive placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose via a single 60-minute (±10 minutes) IV infusion on Day 1. Additionally, participants receive background ABD for 10-21 days per institutional guidelines, at the investigator's discretion.

Outcomes

Primary Outcome Measures

Area Under the Concentration-Time Curve of Bezlotoxumab From Time 0 to Infinity (AUC0-inf)
Blood samples were collected at specified intervals for the determination of AUC0-inf. AUC0-inf was defined as the area under the concentration-time curve of bezlotoxumab from time zero to infinity. Per protocol, AUC0-inf of bezlotoxumab was determined for each age cohort.
Percentage of Participants Who Experienced an Adverse Event (AE)
An AE was defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product and does not imply any judgment about causality. Per protocol, percentage of participants with AEs in the bezlotoxumab and placebo groups were presented.
Percentage of Participants Who Discontinued Study Due to an AE
An AE was defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product and does not imply any judgment about causality. Per protocol, percentage of participants who discontinued study due to AEs in the bezlotoxumab and placebo groups were presented.

Secondary Outcome Measures

Percentage of Participants Who Had a Clostridium Difficile Infection (CDI) Recurrence
CDI recurrence was defined as diarrhea recurrence (new episode of diarrhea after initial clinical response [ICR] as defined by a change in normal bowel habits for ≥2 days with either watery diarrhea or at least 6 unformed bowel movements [UBMs] within 48-hours) associated with a positive stool test for C. difficile toxin, and for which the participant, in the investigator's opinion, requires and receives ABD treatment for CDI. Per protocol, percentage of participants who had a CDI recurrence in the bezlotoxumab and placebo groups were reported.
Percentage of Participants Who Had a Sustained Clinical Response (SCR)
SCR was defined as the ICR of baseline CDI episode (improvement in number and character of bowel movements and doesn't require further CDI therapy within 2 days after completion of up to 21 days of ABD treatment for CDI) and no CDI recurrence (diarrhea recurrence associated with a positive stool test for C. difficile toxin, and for which the participant, in investigator's opinion, requires and receives ABD for CDI). Per protocol, percentage of participants who had a SCR in bezlotoxumab and placebo groups were presented.
Percentage of High-Risk Participants Who Experienced a CDI Recurrence
CDI recurrence was defined as diarrhea recurrence (new diarrhea episode after ICR defined by change in normal bowel habits for ≥2 days with watery diarrhea or at least 6 UBMs within 48-hours) with positive stool test for C. difficile toxin for which participant, in investigator's opinion, requires and receives ABD for CDI. High-risk was meeting ≥1 criteria at/before randomization: a) was immunocompromised b) had ≥1 CDI episode prior to baseline episode c) had severe CDI baseline episode d) had C. difficile ribotype027 in stool at baseline CDI episode e) received ≥1 systemic ABD known to increase CDI risk. Per protocol, percentage of high-risk participants who experienced a CDI recurrence in the bezlotoxumab and placebo groups were presented.
Percentage of High-Risk Participants Who Experienced a SCR
SCR was ICR of baseline CDI episode (improvement in number and character of bowel movements and doesn't require further CDI therapy within 2 days after completion of up to 21 days of ABD for CDI) and no CDI recurrence (diarrhea recurrence with positive stool test for C. difficile toxin, for which participant, in investigator's opinion, requires and receives ABD for CDI). High-risk was meeting ≥1 criteria: a) was immunocompromised b) had ≥1 episodes of CDI prior to baseline episode c) had severe CDI baseline episode d) had C. difficile ribotype027 in stool at baseline CDI episode e) received ≥1 systemic ABD known to increase CDI risk. Per protocol, percentage of high-risk participants who had SCR in bezlotoxumab and placebo groups were presented.
Percentage of Participants Who Experienced One or More Infusion Related Reaction
Infusion related reaction included events meeting any of the 3 criteria: 1) acute onset of an illness involving skin, mucosal tissue, or both and at least 1 of the following: respiratory compromise, reduced blood pressure (BP) or associated symptoms of end-organ dysfunction 2) two or more of the following after onset of study infusion: involving skin-mucosal tissue, respiratory compromise, reduced BP or associated symptoms, or persistent gastrointestinal symptoms 3) reduced BP after onset of infusion or >30% decrease in systolic BP from baseline. Per protocol, percentage of participants experiencing 1 or more infusion-related reactions within 24 hours following the start of study medication infusion were reported.
Percentage of Participants Who Had Positive Antibodies to Bezlotoxumab
Blood samples were collected to determine antibodies to bezlotoxumab. Per protocol, percentage of participants with treatment-emergent positive antibodies to bezlotoxumab following single infusion of bezlotoxumab were reported for each age cohort.

Full Information

First Posted
June 8, 2017
Last Updated
July 25, 2023
Sponsor
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT03182907
Brief Title
Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)
Acronym
MODIFY III
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
May 12, 2022 (Actual)
Study Completion Date
May 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and tolerability of bezlotoxumab (MK-6072) 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.
Detailed Description
Historical adult pharmacokinetic data is from NCT01241552 and NCT01513239.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bezlotoxumab
Arm Type
Experimental
Arm Description
Participants receive 10 mg of bezlotoxumab per kg body weight via a single 60-minute (±10 minutes) intravenous (IV) infusion on Day 1. Additionally, participants receive background antibacterial drug treatment (ABD) for 10-21 days per institutional guidelines, at the investigator's discretion. Dose may then be changed based on results from initial 12 participants.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose via a single 60-minute (±10 minutes) IV infusion on Day 1. Additionally, participants receive background ABD for 10-21 days per institutional guidelines, at the investigator's discretion.
Intervention Type
Biological
Intervention Name(s)
Bezlotoxumab
Other Intervention Name(s)
MK-6072
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A single IV infusion of placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose.
Intervention Type
Drug
Intervention Name(s)
Antibacterial drug treatment (ABD)
Intervention Description
ABD will be administered for 10-21 days including the duration of ABD prior to the screening visit, during the screening period, and after the infusion of study treatment, per institutional guidelines, at the investigator's discretion. ABD is defined as the receipt of oral metronidazole, oral vancomycin, intravenous (IV) metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole.
Primary Outcome Measure Information:
Title
Area Under the Concentration-Time Curve of Bezlotoxumab From Time 0 to Infinity (AUC0-inf)
Description
Blood samples were collected at specified intervals for the determination of AUC0-inf. AUC0-inf was defined as the area under the concentration-time curve of bezlotoxumab from time zero to infinity. Per protocol, AUC0-inf of bezlotoxumab was determined for each age cohort.
Time Frame
Day 1 (2 hours postdose), Days 10, 29, 57, and 85
Title
Percentage of Participants Who Experienced an Adverse Event (AE)
Description
An AE was defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product and does not imply any judgment about causality. Per protocol, percentage of participants with AEs in the bezlotoxumab and placebo groups were presented.
Time Frame
Up to approximately 12 weeks
Title
Percentage of Participants Who Discontinued Study Due to an AE
Description
An AE was defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product and does not imply any judgment about causality. Per protocol, percentage of participants who discontinued study due to AEs in the bezlotoxumab and placebo groups were presented.
Time Frame
Up to approximately 12 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Had a Clostridium Difficile Infection (CDI) Recurrence
Description
CDI recurrence was defined as diarrhea recurrence (new episode of diarrhea after initial clinical response [ICR] as defined by a change in normal bowel habits for ≥2 days with either watery diarrhea or at least 6 unformed bowel movements [UBMs] within 48-hours) associated with a positive stool test for C. difficile toxin, and for which the participant, in the investigator's opinion, requires and receives ABD treatment for CDI. Per protocol, percentage of participants who had a CDI recurrence in the bezlotoxumab and placebo groups were reported.
Time Frame
Up to approximately 12 Weeks
Title
Percentage of Participants Who Had a Sustained Clinical Response (SCR)
Description
SCR was defined as the ICR of baseline CDI episode (improvement in number and character of bowel movements and doesn't require further CDI therapy within 2 days after completion of up to 21 days of ABD treatment for CDI) and no CDI recurrence (diarrhea recurrence associated with a positive stool test for C. difficile toxin, and for which the participant, in investigator's opinion, requires and receives ABD for CDI). Per protocol, percentage of participants who had a SCR in bezlotoxumab and placebo groups were presented.
Time Frame
Up to approximately 12 Weeks
Title
Percentage of High-Risk Participants Who Experienced a CDI Recurrence
Description
CDI recurrence was defined as diarrhea recurrence (new diarrhea episode after ICR defined by change in normal bowel habits for ≥2 days with watery diarrhea or at least 6 UBMs within 48-hours) with positive stool test for C. difficile toxin for which participant, in investigator's opinion, requires and receives ABD for CDI. High-risk was meeting ≥1 criteria at/before randomization: a) was immunocompromised b) had ≥1 CDI episode prior to baseline episode c) had severe CDI baseline episode d) had C. difficile ribotype027 in stool at baseline CDI episode e) received ≥1 systemic ABD known to increase CDI risk. Per protocol, percentage of high-risk participants who experienced a CDI recurrence in the bezlotoxumab and placebo groups were presented.
Time Frame
Up to approximately 12 Weeks
Title
Percentage of High-Risk Participants Who Experienced a SCR
Description
SCR was ICR of baseline CDI episode (improvement in number and character of bowel movements and doesn't require further CDI therapy within 2 days after completion of up to 21 days of ABD for CDI) and no CDI recurrence (diarrhea recurrence with positive stool test for C. difficile toxin, for which participant, in investigator's opinion, requires and receives ABD for CDI). High-risk was meeting ≥1 criteria: a) was immunocompromised b) had ≥1 episodes of CDI prior to baseline episode c) had severe CDI baseline episode d) had C. difficile ribotype027 in stool at baseline CDI episode e) received ≥1 systemic ABD known to increase CDI risk. Per protocol, percentage of high-risk participants who had SCR in bezlotoxumab and placebo groups were presented.
Time Frame
Up to approximately 12 Weeks
Title
Percentage of Participants Who Experienced One or More Infusion Related Reaction
Description
Infusion related reaction included events meeting any of the 3 criteria: 1) acute onset of an illness involving skin, mucosal tissue, or both and at least 1 of the following: respiratory compromise, reduced blood pressure (BP) or associated symptoms of end-organ dysfunction 2) two or more of the following after onset of study infusion: involving skin-mucosal tissue, respiratory compromise, reduced BP or associated symptoms, or persistent gastrointestinal symptoms 3) reduced BP after onset of infusion or >30% decrease in systolic BP from baseline. Per protocol, percentage of participants experiencing 1 or more infusion-related reactions within 24 hours following the start of study medication infusion were reported.
Time Frame
Up to approximately 24 hours after infusion on Day 1
Title
Percentage of Participants Who Had Positive Antibodies to Bezlotoxumab
Description
Blood samples were collected to determine antibodies to bezlotoxumab. Per protocol, percentage of participants with treatment-emergent positive antibodies to bezlotoxumab following single infusion of bezlotoxumab were reported for each age cohort.
Time Frame
Up to approximately 12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At screening has suspected or confirmed Clostridium difficile infection (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital - Los Angeles ( Site 0021)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
UCSF Medical Center ( Site 0049)
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Children's Hospital - Colorado ( Site 0013)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Children's Center for Digestive Healthcare ( Site 0052)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
University of Chicago ( Site 0019)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Our Lady of the Lake Hospital ( Site 0007)
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
The Johns Hopkins Rubenstein Child Health Building ( Site 0034)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Tufts Medical Center-Floating Hospital for Children ( Site 0046)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Mayo Clinic - Rochester ( Site 0004)
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University ( Site 0037)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Montefiore Einstein Center ( Site 0041)
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Columbia University Medical Center/ MSCHONY ( Site 0042)
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
SUNY Upstate Medical Center, University Hospital ( Site 0027)
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke University Health System ( Site 0025)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center ( Site 0024)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
University Hospitals Cleveland Medical Center ( Site 0029)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
St. Jude Children's Research Hospital ( Site 0050)
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Vanderbilt University Medical Center ( Site 0022)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The Children's Hospital of San Antonio ( Site 0009)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Primary Children's Hospital ( Site 0001)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Seattle Childrens Hospital ( Site 0028)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Hospital Italiano de Buenos Aires. ( Site 2103)
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Hospital Privado de Cordoba ( Site 2102)
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Santa Casa de Misericordia de Belo Horizonte ( Site 0208)
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-321
Country
Brazil
Facility Name
Hospital de Clinicas da Universidade Federal do Parana ( Site 0203)
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80060-900
Country
Brazil
Facility Name
Hospital Pequeno Principe ( Site 0200)
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80250-060
Country
Brazil
Facility Name
Hospital Universitario da Universidade Federal de Santa Maria ( Site 0209)
City
Santa Maria
State/Province
Rio Grande Do Sul
ZIP/Postal Code
97105-900
Country
Brazil
Facility Name
Instituto de Oncologia Pediatrica - GRAACC - Unifesp ( Site 0205)
City
Sao Paulo
ZIP/Postal Code
04039-001
Country
Brazil
Facility Name
Hospital Pablo Tobon Uribe-Infectology pediatric ( Site 2166)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
05034
Country
Colombia
Facility Name
Fundacion Cardioinfantil Instituto de Cardiologia ( Site 2163)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110131
Country
Colombia
Facility Name
Fundacion Santa Fe de Bogota ( Site 2167)
City
Bogotá
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110111
Country
Colombia
Facility Name
Fundacion Valle del Lili ( Site 2161)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Facility Name
Centro Medico Imbanaco ( Site 2160)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760042
Country
Colombia
Facility Name
Fakultni Nemocnice Brno Bohunice ( Site 2000)
City
Brno
State/Province
Brno-mesto
ZIP/Postal Code
61300
Country
Czechia
Facility Name
Fakultni nemocnice Plzen ( Site 2001)
City
Plzen Lochotin
State/Province
Plzensky Kraj
ZIP/Postal Code
304 60
Country
Czechia
Facility Name
2. LF UK a FN Motol ( Site 2003)
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Universitaetsklinikum Muenster ( Site 1400)
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitaetsklinikum Hamburg Eppendorf ( Site 1402)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 2200)
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Semmelweis University-II.sz. Gyermekgyógyászati Klinika ( Site 2201)
City
Budapest
ZIP/Postal Code
1094
Country
Hungary
Facility Name
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 2202)
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Sabah Womens & Childrens Hospital ( Site 3101)
City
Kota Kinabalu
State/Province
Sabah
ZIP/Postal Code
88996
Country
Malaysia
Facility Name
Hospital Kuala Lumpur ( Site 3100)
City
Kuala Lumpur
ZIP/Postal Code
50300
Country
Malaysia
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0508)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64400
Country
Mexico
Facility Name
Instituto Tecnologico y de Estudios Superiores de Monterrey ( Site 0502)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Instituto Nacional de Pediatria ( Site 0503)
City
Mexico City
ZIP/Postal Code
04530
Country
Mexico
Facility Name
Hospital Infantil de Mexico Federico Gomez ( Site 0501)
City
Mexico City
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Haukeland universitetssykehus ( Site 1501)
City
Bergen
State/Province
Vestfold
ZIP/Postal Code
5053
Country
Norway
Facility Name
Oslo universitetssykehus ( Site 1500)
City
Oslo
ZIP/Postal Code
0372
Country
Norway
Facility Name
Wojewodzki Szpital Obserwacyjno Zakazny ( Site 2404)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-030
Country
Poland
Facility Name
Wojewodzki Specjalistyczny Szpital im. dr W. Bieganskiego w Lodzi ( Site 2400)
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
91-347
Country
Poland
Facility Name
SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 2405)
City
Lomianki
State/Province
Mazowieckie
ZIP/Postal Code
05-092
Country
Poland
Facility Name
Instytut Pomnik Centrum Zdrowia Dziecka ( Site 2406)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 2410)
City
Olsztyn
State/Province
Warminsko-mazurskie
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Hospital de Braga ( Site 1600)
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 1605)
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Central EPE. Hospital D. Estefania ( Site 1601)
City
Lisboa
ZIP/Postal Code
1169-045
Country
Portugal
Facility Name
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 1603)
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Spitalul Clinic de Boli Infectioase Cluj-Napoca ( Site 2502)
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400348
Country
Romania
Facility Name
Institutul National de Boli Infectioase Prof. Dr. Matei Bals ( Site 2501)
City
Bucuresti
ZIP/Postal Code
021105
Country
Romania
Facility Name
Spitalul Clinic de Boli Infectioase si Tropicale Dr. Victor Babes ( Site 2500)
City
Bucuresti
ZIP/Postal Code
030303
Country
Romania
Facility Name
Spitalul Clinic de Boli Infectioase Constanta ( Site 2504)
City
Constanta
ZIP/Postal Code
900708
Country
Romania
Facility Name
Phoenix Pharma Pty Ltd ( Site 2607)
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6001
Country
South Africa
Facility Name
Johese Clinical Research ( Site 2605)
City
Centurion
State/Province
Gauteng
ZIP/Postal Code
1692
Country
South Africa
Facility Name
Chris Hani Baragwanath Academic Hospital ( Site 2602)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1860
Country
South Africa
Facility Name
Molotlegi Street ( Site 2603)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0208
Country
South Africa
Facility Name
Red Cross War Memorial Children's Hospital ( Site 2601)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Hospital Universitario Sant Joan de Deu ( Site 1704)
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Hospital Infantil Universitario Nino Jesus ( Site 1701)
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario La Paz ( Site 1703)
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio ( Site 1705)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
ITCC Barnokologen Astrid Lindgrens Barnsjukhus NKS ( Site 1800)
City
Stockholm
State/Province
Stockholms Lan
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Barncancercentrum ( Site 1801)
City
Goteborg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
416 85
Country
Sweden
Facility Name
Southampton General Hospital ( Site 1900)
City
Southampton
State/Province
Worcestershire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust ( Site 1901)
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
37389891
Citation
Sferra TJ, Merta T, Neely M, Murta de Oliveira C, Lassaletta A, Fortuny Guasch C, Dorr MB, Winchell G, Su FH, Perko S, Fernsler D, Waskin H, Holden SR. Double-Blind, Placebo-Controlled Study of Bezlotoxumab in Children Receiving Antibacterial Treatment for Clostridioides difficile Infection (MODIFY III). J Pediatric Infect Dis Soc. 2023 Jun 30;12(6):334-341. doi: 10.1093/jpids/piad031.
Results Reference
result
Links:
URL
https://merckclinicaltrials.com/
Description
Merck Clinical Trial Information

Learn more about this trial

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

We'll reach out to this number within 24 hrs