Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication ZINPLAVA™ is indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence. FDA label
Also known as MK-6072
Bezlotoxumab · 2 trials · 1 indication
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.
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.
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.
CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile after clinical cure of the initial CDI episode. Clinical cure is defined as no diarrhea \[2 or fewer loose stools per 24 hours\] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =\< 14 day regimen.
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event. A drug-related adverse event is determined by the investigator to be related to the drug.
A serious adverse event (SAE) is any AE occurring at any dose or during any use of the medicinal product that results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or other important medical events. A serious drug-related adverse event is determined by the investigator to be related to the drug.
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.
| Arm | Type | Description |
|---|---|---|
| Bezlotoxumab | EXPERIMENTAL | 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. |
| Placebo | PLACEBO_COMPARATOR | 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. |
| MK-6072 + SOC | EXPERIMENTAL | Single intravenous (IV) infusion of 10 mg/kg MK-6072 + Standard of Care (SOC) for CDI |
| MK-3415A + SOC | EXPERIMENTAL | Single IV infusion of 10 mg/kg MK-3415A + SOC for CDI |
| Placebo + SOC | PLACEBO_COMPARATOR | Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI |
| Name | Type | Description |
|---|---|---|
| Bezlotoxumab | BIOLOGICAL | 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. |
| Placebo | DRUG | A single IV infusion of placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose. |
| Antibacterial drug treatment (ABD) | DRUG | 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. |
| MK-6072 | BIOLOGICAL | Single IV infusion of MK-6072 (10 mg/kg of monoclonal antibody to C. difficile Toxin B) |
| MK-3415A | BIOLOGICAL | Single IV infusion of MK-3415A (10 mg/kg of monoclonal antibody to C. difficile Toxin A and 10 mg/kg of monoclonal antibody to C. difficile Toxin B) |
| SOC | DRUG | SOC for CDI will be prescribed for 10 to 14 days and can begin on the day of study drug infusion; but the first dose must have been administered prior to or within a few hours following study drug infusion. SOC is defined as the receipt of oral metronidazole, oral vancomycin, IV metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole. |
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...
Bezlotoxumab is used for Clostridium difficile infection (CDI). It is a monoclonal antibody developed by Merck & Company, Inc. (MRK) and has been studied in a Phase 3 trial in children with CDI. The trial compared bezlotoxumab to placebo.
Bezlotoxumab is made by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck developed and studied the drug for Clostridium difficile infection.
Bezlotoxumab is in Phase 3 development. A Phase 3 trial (NCT03182907) has been completed. The drug is investigational and has not been approved by the FDA for any indication.
Bezlotoxumab has been studied in one clinical trial: NCT03182907, a Phase 3 trial titled "Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)." The trial is completed and enrolled 148 participants.
Yes, Bezlotoxumab is also known as MK-6072. The Phase 3 trial for Clostridium difficile infection in children used the name MK-6072 in its title.