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NCT03182907 · ClinicalTrials.gov registry record · Phase 3
Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 148
- Enrollment target
NCT03182907: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT03182907 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 148 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03182907, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 148 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- BIOLOGICAL Bezlotoxumab
- DRUG Antibacterial drug treatment (ABD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2018-03-27 |
| Est. Completion | 2022-05-12 |
| Phase | Phase 3 |
What the finished NCT03182907 record still lists
NCT03182907 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03182907 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03182907 about?
NCT03182907 is a clinical study titled "Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)". 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 h...
What is the current status of trial NCT03182907?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 148 participants. The study started on 2018-03-27. Estimated completion is 2022-05-12.
What interventions are being tested in trial NCT03182907?
The interventions under investigation include: Placebo (DRUG), Bezlotoxumab (BIOLOGICAL), Antibacterial drug treatment (ABD) (DRUG).
Who is sponsoring clinical trial NCT03182907?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03182907's enrollment target sits among peer trials
148 1547th of 2000 higher than 451 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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