Trial · NCT03182907
Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)
NCT03182907, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2023-06-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001). Trials, record NCT03182907. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03182907
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)
- NCT number
- NCT03182907
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 148 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Clostridium Difficile Infection
- Interventions
- Bezlotoxumab, Placebo, Antibacterial drug treatment (ABD)
- First posted
- 2017-06-09
- Last updated
- 2023-07-27
- Other registries' IDs
- eudract:2017-000070-11
- Results first posted
- 2023-06-07
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Concentration-Time Curve of Bezlotoxumab From Time 0 to Infinity (AUC0-inf) | Day 1 (2 hours postdose), Days 10, 29, 57, and 85 | 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. |
| Primary | Percentage of Participants Who Experienced an Adverse Event (AE) | Up to approximately 12 weeks | 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. |
| Primary | Percentage of Participants Who Discontinued Study Due to an AE | Up to approximately 12 weeks | 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 | Percentage of Participants Who Had a Clostridium Difficile Infection (CDI) Recurrence | Up to approximately 12 Weeks | 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. |
| Secondary | Percentage of Participants Who Had a Sustained Clinical Response (SCR) | Up to approximately 12 Weeks | 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. |
| Secondary | Percentage of High-Risk Participants Who Experienced a CDI Recurrence | Up to approximately 12 Weeks | 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. |
| Secondary | Percentage of High-Risk Participants Who Experienced a SCR | Up to approximately 12 Weeks | 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. |
| Secondary | Percentage of Participants Who Experienced One or More Infusion Related Reaction | Up to approximately 24 hours after infusion on Day 1 | 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. |
| Secondary | Percentage of Participants Who Had Positive Antibodies to Bezlotoxumab | Up to approximately 12 Weeks | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Concentration-Time Curve of Bezlotoxumab From Time 0 to Infinity (AUC0-inf) | Day 1 (2 hours postdose), Days 10, 29, 57, and 85 | The analysis population included all participants who received bezlotoxumab, had at least 4 postdose AUC0-inf samples and complied with the protocol. | hr*ug/mL | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Participants Who Experienced an Adverse Event (AE) | Up to approximately 12 weeks | The analysis population included all participants who received study intervention. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued Study Due to an AE | Up to approximately 12 weeks | The analysis population included all participants who received study intervention. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Had a Clostridium Difficile Infection (CDI) Recurrence | Up to approximately 12 Weeks | The analysis population included all participants who received any amount of study intervention, had positive local stool for C. difficile toxin, were taking protocol-defined ABD treatment for CDI on the day of infusion, and achieved an ICR of baseline CDI. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Had a Sustained Clinical Response (SCR) | Up to approximately 12 Weeks | The analysis population included all participants who received any amount of study intervention, had positive local stool for C. difficile toxin, and were taking protocol-defined ABD treatment for CDI on the day of infusion. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of High-Risk Participants Who Experienced a CDI Recurrence | Up to approximately 12 Weeks | The analysis population included all participants who received study intervention, had positive local stool for C. difficile toxin, were taking ABD for CDI on infusion day, achieved ICR of baseline CDI, and were at high-risk of CDI recurrence. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of High-Risk Participants Who Experienced a SCR | Up to approximately 12 Weeks | The analysis population included all participants who received study intervention, had positive local stool for C. difficile toxin, were taking protocol-defined ABD for CDI on the day of infusion, and were at high risk of CDI recurrence. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced One or More Infusion Related Reaction | Up to approximately 24 hours after infusion on Day 1 | The analysis population included all participants who received study intervention. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Had Positive Antibodies to Bezlotoxumab | Up to approximately 12 Weeks | The analysis population included all participants who received any amount of bezlotoxumab, had a positive local stool for C. difficile toxin, were taking protocol-defined ABD drug treatment for CDI on the day of infusion, and achieved an ICR of baseline CDI. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Concentration-Time Curve of Bezlotoxumab From Time 0 to Infinity (AUC0-inf) | Bezlotoxumab: Cohort 1 (12 to <18 Years Age) | 56100 | 95% Confidence Interval 49400 to 63700 | hr*ug/mL | |
| Area Under the Concentration-Time Curve of Bezlotoxumab From Time 0 to Infinity (AUC0-inf) | Bezlotoxumab: Cohort 2 (1 to <12years of Age) | 43200 | 95% Confidence Interval 38900 to 47900 | hr*ug/mL | |
| Percentage of Participants Who Experienced an Adverse Event (AE) | Bezlotoxumab | 88.8 | Percentage of participants | ||
| Percentage of Participants Who Experienced an Adverse Event (AE) | Placebo | 94.4 | Percentage of participants | ||
| Percentage of Participants Who Discontinued Study Due to an AE | Bezlotoxumab | 0 | Percentage of participants | ||
| Percentage of Participants Who Discontinued Study Due to an AE | Placebo | 0 | Percentage of participants | ||
| Percentage of Participants Who Had a Clostridium Difficile Infection (CDI) Recurrence | Bezlotoxumab | 11.2 | Percentage of participants | ||
| Percentage of Participants Who Had a Clostridium Difficile Infection (CDI) Recurrence | Placebo | 14.7 | Percentage of participants | ||
| Percentage of Participants Who Had a Sustained Clinical Response (SCR) | Bezlotoxumab | 83.7 | Percentage of participants | ||
| Percentage of Participants Who Had a Sustained Clinical Response (SCR) | Placebo | 82.9 | Percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bezlotoxumab | 111 | |
| Overall Study | STARTED | Placebo | 37 | |
| Overall Study | Treated | Bezlotoxumab | 107 | |
| Overall Study | Treated | Placebo | 36 | |
| Overall Study | COMPLETED | Bezlotoxumab | 103 | |
| Overall Study | COMPLETED | Placebo | 35 | |
| Overall Study | NOT COMPLETED | Bezlotoxumab | 8 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events220
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Bezlotoxumab | 8 | 107 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 6 | 36 | 10 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Bezlotoxumab | 1 | 107 | 2 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Placebo | 2 | 36 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | Bezlotoxumab | 4 | 107 | 4 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 2 | 36 | 2 |
| other | Neutropenia | Blood and lymphatic system disorders | Bezlotoxumab | 7 | 107 | 7 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 2 | 36 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bezlotoxumab | 7 | 107 | 8 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 3 | 36 | 3 |
1 to 10 of 220Source ClinicalTrials.gov
See all 220 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bezlotoxumab | 6 | 111 |
| Total, all-cause mortality | Placebo | 1 | 37 |
| Total, other adverse events | Bezlotoxumab | 65 | 107 |
| Total, other adverse events | Placebo | 28 | 36 |
| Total, serious adverse events | Bezlotoxumab | 57 | 107 |
| Total, serious adverse events | Placebo | 29 | 36 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37389891 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Bezlotoxumab vs Placebo: deaths from any cause | Trial comparisons |
| Bezlotoxumab vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03182907
GET https://conductscience.org/api/trials/v1/NCT03182907/events?page=2