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CompletedNCT01241552MODIFY IUpdated Sep 5, 2018Results posted

A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001)

A Phase 3 interventional study of MK-3415 and MK-6072 in Clostridium Difficile Infection, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,452
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will investigate whether: 1) treatment with MK-3415A in addition to standard of care (SOC) antibiotic therapy will decrease Clostridium difficile infection (CDI) recurrence as compared to treatment with MK-6072 or MK-3415, 2) treatment with MK-3415A, MK-6072, or MK-3415, in addition to SOC antibiotic therapy will decrease CDI recurrence as compared to placebo, and 3) MK-3415A, MK-6072, and MK-3415 will be generally well tolerated in participants receiving SOC therapy for CDI as compared to placebo.

02

Conditions studied

  • Clostridium Difficile Infection

Keywords

  • Clostridium difficile
  • recurrent Clostridium difficile
  • vancomycin
  • metronidazole
  • monoclonal antibody
  • Clostridium difficile infection (CDI)
03

In context

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 1,452 is above the median of 120 across 4,201 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • participant has a confirmed diagnosis of CDI as defined by: a. diarrhea, as defined by passage of 3 or more loose stools in 24 or fewer hours, AND b. A positive test for toxigenic C. difficile from a stool collected no more than 7 days before study infusion.
  • participant must be receiving SOC therapy for CDI. SOC therapy 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.
  • participant is highly unlikely to become pregnant or to impregnate a partner since they meet at least one of the following criteria: a. A female participant who is not of reproductive potential is eligible without requiring the use of contraception. A female participant who is not of reproductive potential is defined as: one who has either (1) reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels in the postmenopausal range as determined by the local laboratory, or 12 months of spontaneous amenorrhea); (2) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy; or (3) bilateral tubal ligation. Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (e.g. anorexia nervosa). b. A participant who is of reproductive potential agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control starting at enrollment and through the 12 Week study period. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy and any registered and marketed hormonal contraceptives that contain an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)
  • participant or legal representative must have voluntarily agreed to participate by providing written informed consent after the nature of the study has been fully explained.

Exclusion criteria

Exclusion Criteria:

  • participant with an uncontrolled chronic diarrheal illness such that their normal 24-hour bowel movement habit is 3 or more loose stools.
  • participant with a planned surgery for CDI within 24 hours.
  • participant has a positive pregnancy test in the 48 hours before the infusion or is unwilling to undergo pregnancy testing if a pre-menopausal female who is not sterilized and therefore has the potential to bear a child.
  • participant is breast-feeding or plans to breast-feed prior to the completion of the 12-week study period.
  • A female participant who plans to donate ova prior to the completion of the 12-week study period, or a male participant who is planning to impregnate or provide sperm donation prior to the completion of the 12-week study period.
  • participant has previously participated in this study, has previously received MK-3415 or MK- 6072 (either alone or in combination), has received a C. difficile vaccine, or has received another experimental monoclonal antibody against C. difficile toxin A or B.
  • participant plans to donate blood and/or blood products within 6 months following the infusion.
  • participant has received immune globulin within 6 months prior to receipt of the infusion or is planning to receive immune globulin prior to the completion of the 12-week study period.
  • treatment with SOC therapy is planned for longer than 14 days.
  • participant has received more than a 24-hour regimen of cholestyramine, colestimide, rifaximin, or nitazoxanide within 14 days prior to receipt of the infusion or is planning to receive these medications prior to the completion of the 12-week study period.
  • participant plans to take medications that are given to decrease gastrointestinal peristalsis, such as loperamide (Imodium™) or diphenoxylate hydrochloride/atropine sulfate (LOMOTIL™), at any time during the 14 days following infusion. Participants receiving opioid medications at the onset of diarrhea may be included if they are on a stable dose or if there is anticipation of a dose decrease or cessation of use.
  • participant plans to take the probiotic Saccharomyces boulardii or receive fecal transplant therapy, or any other therapies that have been demonstrated to decrease CDI recurrences at any time following infusion (Day 1) and through the completion of the 12-week study period.
  • participant has received another investigational study agent within the previous 30 days, or is currently participating in or scheduled to participate in any other clinical trial with an investigational agent during the 12-week study period.
  • participant is not expected to survive for 72 hours.
  • participant has any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant participating in the study, would make it unlikely for the participant to complete the study, or would confound the results of the study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,452 participants (actual)

Study arms

  • Experimental
    MK-3415 + SOC

    Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI

    Biological: MK-3415 · Drug: SOC

  • Experimental
    MK-6072 + SOC

    Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI

    Biological: MK-6072 · Drug: SOC

  • Experimental
    MK-3415A + SOC

    Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI

    Biological: MK-3415A · Drug: SOC

  • Placebo comparator
    Placebo + SOC

    Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI

    Biological: Placebo · Drug: SOC

Interventions

  • BiologicalMK-3415

    A single IV infusion of MK-3415 (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin A)

  • BiologicalMK-6072

    A single infusion of MK-6072 (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin B)

  • BiologicalMK-3415A

    A single IV infusion of MK-3415A (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin A and 10mg/kg of monoclonal antibody to Clostridium difficile Toxin B)

  • BiologicalPlacebo

    A single IV infusion of normal saline (0.9% sodium chloride)

  • DrugSOC

    Standard of care (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 metranidazole, oral vancomycin, IV metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Clostridium Difficile Infection (CDI) Recurrence

    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 local or central lab stool test for toxigenic Clostridium (C.) difficile following clinical cure of the initial CDI episode

    Time frame: Up to 12 weeks

  2. Percentage of Participants With One or More Adverse Events (AEs) During 4 Weeks Following Infusion

    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

    Time frame: Up to 28 days

  3. Percentage of Participants With Any Drug-related AE During 4 Weeks Following Infusion

    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE was an AE determined by the investigator to be related to the drug.

    Time frame: Up to 28 days

  4. Percentage of Participants With Any Serious Adverse Events (SAEs) During 4 Weeks Following Infusion

    A SAE is any AE occurring at any dose or during any use of Sponsor's 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 is a cancer, or is associated with an overdose (whether accidental or intentional); or is other important medical events.

    Time frame: Up to 28 days

  5. Percentage of Participants With Any Serious Drug-related Adverse Events During 4 Weeks Following Infusion

    A SAE is any AE occurring at any dose or during any use of Sponsor's 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 is a cancer, or is associated with an overdose (whether accidental or intentional); or is other important medical events. A serious drug-related AE was a SAE determined by the investigator to be related to the drug.

    Time frame: Up to 28 days

  6. Percentage of Participants Who Discontinued Study Medication Due to an AE During 4 Weeks Following Infusion

    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol-specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

    Time frame: Up to 28 days

  7. Percentage of Participants With Infusion-specific AEs

    Infusion-specific AEs included local infusion site AEs; and systemic AEs which include nausea, vomiting, chills, fatigue, feeling hot, infusion site conditions (bruising, coldness, erythema, extravasation, pain, phlebitis, pruritus), pyrexia, arthralgia, musculoskeletal pain, myalgia, dizziness, headache, dysphonia, nasal congestion, pruritus, rash, pruritic rash, urticaria, flushing, hot flush, hypertension, and hypotension.

    Time frame: Up to 24 hours

Secondary outcomes

  1. Percentage of Participants With Global Cure

    Global Cure is defined as the clinical cure of the initial CDI episode and no CDI recurrence through Week 12. Clinical cure is defined as participants who received ≤ 14 day regimen of SOC therapy and have no diarrhea (≤2 loose stools per 24 hours) for two consecutive days following completion of SOC therapy for the initial CDI episode.

    Time frame: Up to 12 weeks

  2. Percentage of Participants With CDI Recurrence in Those With Clinical Cure of the Initial CDI Episode

    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 local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Clinical cure is defined as participants who received ≤ 14 day regimen of SOC therapy and have no diarrhea (≤2 loose stools per 24 hours) for two consecutive days following completion of SOC therapy for the baseline CDI episode.

    Time frame: Up to 12 weeks

  3. Percentage of Participants ≥ 65 Years of Age at Study Entry With CDI Recurrence

    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 local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.

    Time frame: Up to 12 weeks

  4. Percentage of Participants With a History of CDI in the 6 Months Prior to Enrollment With CDI Recurrence

    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 local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.

    Time frame: Up to 12 weeks

  5. Percentage of Participants With Clinically Severe CDI at Study Entry With CDI Recurrence

    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 local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Clinically severe CDI is defined as a Zar Score ≥ 2 based on the presence of 1 or more of the following: 1) age \>60 years old (1 point); 2)body temperature \>38.3°C (\>100°F) (1 point); 3) albumin level ˂2.5 mg/dL (1 point); 4) peripheral white blood cell count \>15,000 cells/mm\^3 within 48 hours (1 point); 5) endoscopic evidence of pseudomembranous colitis (2 points); and 6) treatment in Intensive Care Unit (2 points).

    Time frame: Up to 12 weeks

  6. Percentage of Participants With the B1/NAP1/027 Strain of C. Difficile at Study Entry With CDI Recurrence

    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 local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.

    Time frame: Up to 12 weeks

  7. Percentage of Participants With an Epidemic Strain of C. Difficile (Ribotypes 027, 014, 002, 001, 106, and 020) at Study Entry With CDI Recurrence

    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 local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.

    Time frame: Up to 12 weeks

  8. Percentage of Participants With Compromised Immunity at Study Entry With CDI Recurrence

    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 local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Compromised immunity is defined as follows: an active hematological malignancy (including leukemia, lymphoma, multiple myeloma), an active malignancy requiring recent cytotoxic chemotherapy, receipt of a prior hematopoietic stem cell transplant, receipt of a prior solid organ transplant, asplenia, or neutropenia/pancytopenia due to other conditions.

    Time frame: Up to 12 weeks

07

Results

Posted Dec 15, 2016

Participant flow

Participant flow — Overall Study
MilestoneMK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOC
Started242403403404
Treated235392388397
Completed201340343340
Not completed41636064
Withdrew: Lack of efficacy1000
Withdrew: Death26302025
Withdrew: Adverse event1100
Withdrew: Technical problems2022
Withdrew: Progressive disease0012
Withdrew: Protocol violation0261
Withdrew: Withdrawal by subject7151415
Withdrew: Physician decision2423
Withdrew: Lost to follow-up2111516

Outcome measures

PrimaryPercentage of Participants With Clostridium Difficile Infection (CDI) Recurrence

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 local or central lab stool test for toxigenic Clostridium (C.) difficile following clinical cure of the initial CDI episode

Time frame:
Up to 12 weeks
Reported as:
Number · Percentage of participants
Percentage of Participants With Clostridium Difficile Infection (CDI) Recurrence
Percentage of participantsMK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOC
Percentage of Participants With Clostridium Difficile Infection (CDI) Recurrence25.917.415.927.6
Statistical analysis
  • MK-3415 + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.3182 (One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).) · Adjusted difference: -1.7 · 95% CI -8.6 to 5.5Adjusted Difference: MK-3415 + SOC - Placebo + SOC
  • MK-6072 + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.0003 (One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).) · Adjusted difference: -10.1 · 95% CI -15.9 to -4.3Adjusted Difference: MK-6072 + SOC - Placebo + SOC
  • MK-3415A + SOC vs Placebo + SOC · Miettinen and Nurminen · p = < 0.0001 (One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).) · Adjusted difference: -11.6 · 95% CI -17.4 to -5.9Adjusted Difference: MK-3415A + SOC - Placebo + SOC
  • MK-3415 + SOC vs MK-3415A + SOC · Miettinen and Nurminen · p = 0.0013 (One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).) · Adjusted difference: -9.9 · 95% CI -16.9 to -3.4Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC
  • MK-6072 + SOC vs MK-3415A + SOC · Miettinen and Nurminen · p = 0.2997 (One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).) · Adjusted difference: -1.4 · 95% CI -6.7 to 3.9Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC
SecondaryPercentage of Participants With Global Cure

Global Cure is defined as the clinical cure of the initial CDI episode and no CDI recurrence through Week 12. Clinical cure is defined as participants who received ≤ 14 day regimen of SOC therapy and have no diarrhea (≤2 loose stools per 24 hours) for two consecutive days following completion of SOC therapy for the initial CDI episode.

Time frame:
Up to 12 weeks
Reported as:
Number · Percentage of participants
Percentage of Participants With Global Cure
Percentage of participantsMK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOC
Percentage of Participants With Global Cure47.060.158.755.2
Statistical analysis
  • MK-3415 + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.9775 (One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).) · Adjusted difference: -8.3 · 95% CI -16.3 to -0.2Adjusted Difference: MK-3415 + SOC - Placebo + SOC
  • MK-6072 + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.0861 (One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).) · Adjusted difference: 4.8 · 95% CI -2.1 to 11.7Adjusted Difference: MK-6072 + SOC - Placebo + SOC
  • MK-3415A + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.1646 (One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).) · Adjusted difference: 3.5 · 95% CI -3.5 to 10.4Adjusted Difference: MK-3415A + SOC - Placebo + SOC
  • MK-3415 + SOC vs MK-3415A + SOC · Miettinen and Nurminen · p = 0.0025 (One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).) · Adjusted difference: 11.7 · 95% CI 3.5 to 19.7Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC
  • MK-6072 + SOC vs MK-3415A + SOC · Miettinen and Nurminen · p = 0.6532 (One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).) · Adjusted difference: -1.4 · 95% CI -8.3 to 5.5Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC
SecondaryPercentage of Participants With CDI Recurrence in Those With Clinical Cure of the Initial CDI Episode

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 local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Clinical cure is defined as participants who received ≤ 14 day regimen of SOC therapy and have no diarrhea (≤2 loose stools per 24 hours) for two consecutive days following completion of SOC therapy for the baseline CDI episode.

Time frame:
Up to 12 weeks
Reported as:
Number · Percentage of participants
Percentage of Participants With CDI Recurrence in Those With Clinical Cure of the Initial CDI Episode
Percentage of participantsMK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOC
Percentage of Participants With CDI Recurrence in Those With Clinical Cure of the Initial CDI Episode35.522.421.333.3
Statistical analysis
  • MK-3415 + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.6505 (One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).) · Adjusted difference: 1.7 · 95% CI -6.9 to 10.7Adjusted Difference: MK-3415 + SOC - Placebo + SOC
  • MK-6072 + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.0013 (One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).) · Adjusted difference: -10.8 · 95% CI -17.7 to -3.8Adjusted Difference: MK-6072 + SOC - Placebo + SOC
  • MK-3415A + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.0006 (One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).) · Adjusted difference: -11.7 · 95% CI -18.6 to -4.7Adjusted Difference: MK-3415A + SOC - Placebo + SOC
  • MK-3415 + SOC vs MK-3415A + SOC · Miettinen and Nurminen · p = 0.0007 (One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).) · Adjusted difference: -13.7 · 95% CI -22.5 to -5.2Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC
  • MK-6072 + SOC vs MK-3415A + SOC · Miettinen and Nurminen · p = 0.3906 (One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).) · Adjusted difference: -1.0 · 95% CI -7.7 to 5.8Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC
PrimaryPercentage of Participants With One or More Adverse Events (AEs) During 4 Weeks Following Infusion

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

Time frame:
Up to 28 days
Reported as:
Number · Percentage of participants
Percentage of Participants With One or More Adverse Events (AEs) During 4 Weeks Following Infusion
Percentage of participantsMK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOC
Percentage of Participants With One or More Adverse Events (AEs) During 4 Weeks Following Infusion67.265.459.762.0
Statistical analysis
  • MK-3415 + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.185 · Percentage difference: 5.2 · 95% CI -2.5 to 12.8Percentage Difference: MK-3415 + SOC - Placebo + SOC
  • MK-6072 + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.323 · Percentage difference: 3.4 · 95% CI -3.3 to 10.1Percentage Difference: MK-6072 + SOC - Placebo + SOC
  • MK-3415A + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.507 · Percentage difference: -2.3 · 95% CI -9.1 to 4.5Percentage Difference: MK-3415A + SOC - Placebo + SOC
PrimaryPercentage of Participants With Any Drug-related AE During 4 Weeks Following Infusion

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE was an AE determined by the investigator to be related to the drug.

Time frame:
Up to 28 days
Reported as:
Number · Percentage of participants
Percentage of Participants With Any Drug-related AE During 4 Weeks Following Infusion
Percentage of participantsMK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOC
Percentage of Participants With Any Drug-related AE During 4 Weeks Following Infusion7.28.26.25.0
Statistical analysis
  • MK-3415 + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.246 · Percentage difference: 2.2 · 95% CI -1.5 to 6.7Percentage Difference: MK-3415 + SOC - Placebo + SOC
  • MK-6072 + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.069 · Percentage difference: 3.2 · 95% CI -0.3 to 6.8Percentage Difference: MK-6072 + SOC - Placebo + SOC
  • MK-3415A + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.464 · Percentage difference: 1.2 · 95% CI -2.1 to 4.6Percentage Difference: MK-3415A + SOC - Placebo + SOC
PrimaryPercentage of Participants With Any Serious Adverse Events (SAEs) During 4 Weeks Following Infusion

A SAE is any AE occurring at any dose or during any use of Sponsor's 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 is a cancer, or is associated with an overdose (whether accidental or intentional); or is other important medical events.

Time frame:
Up to 28 days
Reported as:
Number · Percentage of participants
Percentage of Participants With Any Serious Adverse Events (SAEs) During 4 Weeks Following Infusion
Percentage of participantsMK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOC
Percentage of Participants With Any Serious Adverse Events (SAEs) During 4 Weeks Following Infusion27.721.514.720.0
Statistical analysis
  • MK-3415 + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.027 · Percentage difference: 7.7 · 95% CI 0.9 to 14.7Percentage Difference: MK-3415 + SOC - Placebo + SOC
  • MK-6072 + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.594 · Percentage difference: 1.5 · 95% CI -4.1 to 7.2Percentage Difference: MK-6072 + SOC - Placebo + SOC
  • MK-3415A + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.051 · Percentage difference: -5.3 · 95% CI -10.6 to 0.0Percentage Difference: MK-3415A + SOC - Placebo + SOC
PrimaryPercentage of Participants With Any Serious Drug-related Adverse Events During 4 Weeks Following Infusion

A SAE is any AE occurring at any dose or during any use of Sponsor's 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 is a cancer, or is associated with an overdose (whether accidental or intentional); or is other important medical events. A serious drug-related AE was a SAE determined by the investigator to be related to the drug.

Time frame:
Up to 28 days
Reported as:
Number · Percentage of participants
Percentage of Participants With Any Serious Drug-related Adverse Events During 4 Weeks Following Infusion
Percentage of participantsMK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOC
Percentage of Participants With Any Serious Drug-related Adverse Events During 4 Weeks Following Infusion1.31.00.50.3
Statistical analysis
  • MK-3415 + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.115 · Percentage difference: 1.0 · 95% CI -0.3 to 3.5Percentage Difference: MK-3415 + SOC - Placebo + SOC
  • MK-6072 + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.170 · Percentage difference: 0.8 · 95% CI -0.5 to 2.4Percentage Difference: MK-6072 + SOC - Placebo + SOC
  • MK-3415A + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.544 · Percentage difference: 0.3 · 95% CI -0.9 to 1.6Percentage Difference: MK-3415A + SOC - Placeb + SOC
PrimaryPercentage of Participants Who Discontinued Study Medication Due to an AE During 4 Weeks Following Infusion

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol-specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

Time frame:
Up to 28 days
Reported as:
Number · Percentage of participants
Percentage of Participants Who Discontinued Study Medication Due to an AE During 4 Weeks Following Infusion
Percentage of participantsMK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOC
Percentage of Participants Who Discontinued Study Medication Due to an AE During 4 Weeks Following Infusion0.40.30.00.0
Statistical analysis
  • MK-3415 + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.192 · Percentage difference: 0.4 · 95% CI -0.5 to 2.4Percentage Difference: MK-3415 + SOC - Placebo + SOC
  • MK-6072 + SOC vs Placebo + SOC · Miettinen and Nurminen · p = 0.311 · Percentage difference: 0.3 · 95% CI -0.7 to 1.4Percentage Difference: MK-6072 + SOC - Placebo + SOC
  • MK-3415A + SOC vs Placebo + SOC · Miettinen and Nurminen · p = > 0.999 · Percentage difference: 0.0 · 95% CI -1.0 to 1.0Percentage Difference: MK-3415A + SOC - Placebo + SOC
PrimaryPercentage of Participants With Infusion-specific AEs

Infusion-specific AEs included local infusion site AEs; and systemic AEs which include nausea, vomiting, chills, fatigue, feeling hot, infusion site conditions (bruising, coldness, erythema, extravasation, pain, phlebitis, pruritus), pyrexia, arthralgia, musculoskeletal pain, myalgia, dizziness, headache, dysphonia, nasal congestion, pruritus, rash, pruritic rash, urticaria, flushing, hot flush, hypertension, and hypotension.

Time frame:
Up to 24 hours
Reported as:
Number · Percentage of participants
Percentage of Participants With Infusion-specific AEs
Percentage of participantsMK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOC
Percentage of Participants With Infusion-specific AEs11.111.88.87.5
Statistical analysis
  • MK-3415 + SOC vs Placebo + SOC · Percentage difference: 3.6 · 95% CI -1.0 to 8.7Percentage Difference: MK-3415 + SOC - Placebo + SOC
  • MK-6072 + SOC vs Placebo + SOC · Percentage difference: 4.3 · 95% CI 0.2 to 8.5Percentage Difference: MK-6072 + SOC - Placebo + SOC
  • MK-3415A + SOC vs Placebo + SOC · Percentage difference: 1.3 · 95% CI -2.6 to 5.2Percentage Difference: MK-3415A + SOC - Placebo + SOC
SecondaryPercentage of Participants ≥ 65 Years of Age at Study Entry With CDI Recurrence

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 local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.

Time frame:
Up to 12 weeks
Reported as:
Number · Percentage of participants
Percentage of Participants ≥ 65 Years of Age at Study Entry With CDI Recurrence
Percentage of participantsMK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOC
Percentage of Participants ≥ 65 Years of Age at Study Entry With CDI Recurrence26.215.117.033.2
Statistical analysis
  • MK-3415 + SOC vs Placebo + SOC · Percentage difference: -6.9 · 95% CI -16.8 to 3.5Percentage Difference: MK-3415 + SOC - Placebo + SOC
  • MK-6072 + SOC vs Placebo + SOC · Percentage difference: -18.0 · 95% CI -26.3 to -9.6Percentage Difference: MK-6072 + SOC - Placebo + SOC
  • MK-3415A + SOC vs Placebo + SOC · Percentage difference: -16.2 · 95% CI -24.5 to -7.7Percentage Difference: MK-3415A + SOC - Placebo + SOC
SecondaryPercentage of Participants With a History of CDI in the 6 Months Prior to Enrollment With CDI Recurrence

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 local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.

Time frame:
Up to 12 weeks
Reported as:
Number · Percentage of participants
Percentage of Participants With a History of CDI in the 6 Months Prior to Enrollment With CDI Recurrence
Percentage of participantsMK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOC
Percentage of Participants With a History of CDI in the 6 Months Prior to Enrollment With CDI Recurrence33.326.225.039.4
Statistical analysis
  • MK-3415 + SOC vs Placebo + SOC · Percentage difference: -6.1 · 95% CI -20.1 to 8.6Percentage Difference: MK-3415 + SOC - Placebo + SOC
  • MK-6072 + SOC vs Placebo + SOC · Percentage difference: -13.2 · 95% CI -25.5 to -0.5Percentage Difference: MK-6072 + SOC - Placebo + SOC
  • MK-3415A + SOC vs Placebo + SOC · Percentage difference: -14.4 · 95% CI -26.8 to -1.6Percentage Difference: MK-3415A + SOC - Placebo + SOC
SecondaryPercentage of Participants With Clinically Severe CDI at Study Entry With CDI Recurrence

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 local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Clinically severe CDI is defined as a Zar Score ≥ 2 based on the presence of 1 or more of the following: 1) age \>60 years old (1 point); 2)body temperature \>38.3°C (\>100°F) (1 point); 3) albumin level ˂2.5 mg/dL (1 point); 4) peripheral white blood cell count \>15,000 cells/mm\^3 within 48 hours (1 point); 5) endoscopic evidence of pseudomembranous colitis (2 points); and 6) treatment in Intensive Care Unit (2 points).

Time frame:
Up to 12 weeks
Reported as:
Number · Percentage of participants
Percentage of Participants With Clinically Severe CDI at Study Entry With CDI Recurrence
Percentage of participantsMK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOC
Percentage of Participants With Clinically Severe CDI at Study Entry With CDI Recurrence25.810.412.925.0
Statistical analysis
  • MK-3415 + SOC vs Placebo + SOC · Percentage difference: 0.8 · 95% CI -16.9 to 21.0Percentage Difference: MK-3415 + SOC - Placebo + SOC
  • MK-6072 + SOC vs Placebo + SOC · Percentage difference: -14.6 · 95% CI -28.3 to -1.4Percentage Difference: MK-6072 + SOC - Placebo + SOC
  • MK-3415A + SOC vs Placebo + SOC · Percentage difference: -12.1 · 95% CI -26.2 to 1.9Percentage Difference: MK-3415A + SOC - Placebo + SOC
SecondaryPercentage of Participants With the B1/NAP1/027 Strain of C. Difficile at Study Entry With CDI Recurrence

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 local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.

Time frame:
Up to 12 weeks
Reported as:
Number · Percentage of participants
Percentage of Participants With the B1/NAP1/027 Strain of C. Difficile at Study Entry With CDI Recurrence
Percentage of participantsMK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOC
Percentage of Participants With the B1/NAP1/027 Strain of C. Difficile at Study Entry With CDI Recurrence33.326.110.836.1
Statistical analysis
  • MK-6072 + SOC vs Placebo + SOC · Percentage difference: -10.0 · 95% CI -30.1 to 10.0Percentage Difference: MK-6072 + SOC - Placebo + SOC
  • MK-3415A + SOC vs Placebo + SOC · Percentage difference: -25.3 · 95% CI -43.7 to -6.1Percentage Difference: MK-3415A + SOC - Placebo + SOC
SecondaryPercentage of Participants With an Epidemic Strain of C. Difficile (Ribotypes 027, 014, 002, 001, 106, and 020) at Study Entry With CDI Recurrence

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 local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.

Time frame:
Up to 12 weeks
Reported as:
Number · Percentage of participants
Percentage of Participants With an Epidemic Strain of C. Difficile (Ribotypes 027, 014, 002, 001, 106, and 020) at Study Entry With CDI Recurrence
Percentage of participantsMK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOC
Percentage of Participants With an Epidemic Strain of C. Difficile (Ribotypes 027, 014, 002, 001, 106, and 020) at Study Entry With CDI Recurrence24.623.119.835.8
Statistical analysis
  • MK-3415 + SOC vs Placebo + SOC · Percentage difference: -11.3 · 95% CI -24.9 to 3.9Percentage Difference: MK-3415 + SOC - Placebo + SOC
  • MK-6072 + SOC vs Placebo + SOC · Percentage difference: -12.7 · 95% CI -24.7 to -0.5Percentage Difference: MK-6072 + SOC - Placebo + SOC
  • MK-3415A + SOC vs Placebo + SOC · Percentage difference: -16.0 · 95% CI -27.8 to -4.0Percentage Difference: MK-3415A + SOC - Placebo + SOC
SecondaryPercentage of Participants With Compromised Immunity at Study Entry With CDI Recurrence

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 local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Compromised immunity is defined as follows: an active hematological malignancy (including leukemia, lymphoma, multiple myeloma), an active malignancy requiring recent cytotoxic chemotherapy, receipt of a prior hematopoietic stem cell transplant, receipt of a prior solid organ transplant, asplenia, or neutropenia/pancytopenia due to other conditions.

Time frame:
Up to 12 weeks
Reported as:
Number · Percentage of participants
Percentage of Participants With Compromised Immunity at Study Entry With CDI Recurrence
Percentage of participantsMK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOC
Percentage of Participants With Compromised Immunity at Study Entry With CDI Recurrence18.217.211.528.3
Statistical analysis
  • MK-3415 + SOC vs Placebo + SOC · Percentage difference: -10.1 · 95% CI -23.2 to 4.6Percentage Difference: MK-3415 + SOC - Placebo + SOC
  • MK-6072 + SOC vs Placebo + SOC · Percentage difference: -11.0 · 95% CI -23.2 to 1.4Percentage Difference: MK-6072 + SOC - Placebo + SOC
  • MK-3415A + SOC vs Placebo + SOC · Percentage difference: -16.7 · 95% CI -28.4 to -4.7Percentage Difference: MK-3415A + SOC - Placebo + SOC

Adverse events

Collected over Up to 90 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MK-3415 + SOC—104/235 (44.3%)84/235 (35.7%)
MK-6072 + SOC—120/390 (30.8%)116/390 (29.7%)
MK-3415A + SOC—94/387 (24.3%)110/387 (28.4%)
Placebo + SOC—126/400 (31.5%)103/400 (25.8%)
Most frequent serious events
Showing 10 of 282
Most frequent serious events
EventMK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOC
Clostridium difficile infectionInfections and infestations26/23510/39018/38726/400
SepsisInfections and infestations9/2357/3903/38711/400
PneumoniaInfections and infestations7/2357/3905/38711/400
DiarrhoeaGastrointestinal disorders6/2359/3906/3876/400
Urinary tract infectionInfections and infestations6/2356/3904/3875/400
Abdominal painGastrointestinal disorders4/2353/3904/3872/400
Renal failure acuteRenal and urinary disorders3/2355/3903/3876/400
Cardiac failureCardiac disorders3/2354/3901/3874/400
ConstipationGastrointestinal disorders3/2351/3900/3870/400
NauseaGastrointestinal disorders3/2350/3900/3871/400
Most frequent other events
Most frequent other events
EventMK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOC
NauseaGastrointestinal disorders30/23532/39033/38730/400
DiarrhoeaGastrointestinal disorders18/23525/39033/38727/400
Abdominal painGastrointestinal disorders14/23525/39020/38724/400
Urinary tract infectionInfections and infestations15/23518/39015/38720/400
HeadacheNervous system disorders15/23520/39022/38714/400
PyrexiaGeneral disorders14/23523/39013/38715/400
VomitingGastrointestinal disorders11/23523/39015/38716/400
FatigueGeneral disorders12/2357/39014/3875/400

Baseline characteristics

Age, Continuous
Age, Continuous(Years)MK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOCTotal
Mean64.2 ± 16.861.1 ± 18.562.5 ± 17.862.9 ± 18.362.5 ± 18.0
Sex: Female, Male
Sex: Female, Male(Participants)MK-3415 + SOCMK-6072 + SOCMK-3415A + SOCPlacebo + SOCTotal
Female137238224230829
Male105165179174623
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Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Bouza E, Cornely OA, Ramos-Martinez A, Plesniak R, Ellison MC, Hanson ME, Dorr MB. Analysis of C. difficile infection-related outcomes in European participants in the bezlotoxumab MODIFY I and II trials. Eur J Clin Microbiol Infect Dis. 2020 Oct;39(10):1933-1939. doi: 10.1007/s10096-020-03935-3. Epub 2020 Jun 6. PubMed 32504314 ↗
  • Shen J, Mehrotra DV, Dorr MB, Zeng Z, Li J, Xu X, Nickle D, Holzinger ER, Chhibber A, Wilcox MH, Blanchard RL, Shaw PM. Genetic Association Reveals Protection against Recurrence of Clostridium difficile Infection with Bezlotoxumab Treatment. mSphere. 2020 May 6;5(3):e00232-20. doi: 10.1128/mSphere.00232-20. PubMed 32376702 ↗
  • Cornely OA, Mullane KM, Birch T, Hazan-Steinberg S, Nathan R, Bouza E, Calfee DP, Ellison MC, Wong MT, Dorr MB. Exploratory Evaluation of Bezlotoxumab on Outcomes Associated With Clostridioides difficile Infection in MODIFY I/II Participants With Cancer. Open Forum Infect Dis. 2020 Jan 31;7(2):ofaa038. doi: 10.1093/ofid/ofaa038. eCollection 2020 Feb. PubMed 32099847 ↗
  • Kelly CP, Poxton IR, Shen J, Wilcox MH, Gerding DN, Zhao X, Laterza OF, Railkar R, Guris D, Dorr MB. Effect of Endogenous Clostridioides difficile Toxin Antibodies on Recurrence of C. difficile Infection. Clin Infect Dis. 2020 Jun 24;71(1):81-86. doi: 10.1093/cid/ciz809. PubMed 31628838 ↗
  • Montgomery DL, Matthews RP, Yee KL, Tobias LM, Dorr MB, Wrishko RE. Assessment of Bezlotoxumab Immunogenicity. Clin Pharmacol Drug Dev. 2020 Apr;9(3):330-340. doi: 10.1002/cpdd.729. Epub 2019 Aug 14. PubMed 31411386 ↗
  • Basu A, Prabhu VS, Dorr MB, Golan Y, Dubberke ER, Cornely OA, Heimann SM, Pedley A, Xu R, Hanson ME, Marcella S. Bezlotoxumab Is Associated With a Reduction in Cumulative Inpatient-Days: Analysis of the Hospitalization Data From the MODIFY I and II Clinical Trials. Open Forum Infect Dis. 2018 Nov 15;5(11):ofy218. doi: 10.1093/ofid/ofy218. eCollection 2018 Nov. PubMed 30460321 ↗
  • Yee KL, Kleijn HJ, Kerbusch T, Matthews RP, Dorr MB, Garey KW, Wrishko RE. Population Pharmacokinetics and Pharmacodynamics of Bezlotoxumab in Adults with Primary and Recurrent Clostridium difficile Infection. Antimicrob Agents Chemother. 2019 Jan 29;63(2):e01971-18. doi: 10.1128/AAC.01971-18. Print 2019 Feb. PubMed 30455246 ↗
  • Kelly CP, Wilcox MH, Glerup H, Aboo N, Ellison MC, Eves K, Dorr MB. Bezlotoxumab for Clostridium difficile Infection Complicating Inflammatory Bowel Disease. Gastroenterology. 2018 Oct;155(4):1270-1271. doi: 10.1053/j.gastro.2018.06.080. Epub 2018 Sep 15. No abstract available. PubMed 30227108 ↗
  • Prabhu VS, Cornely OA, Golan Y, Dubberke ER, Heimann SM, Hanson ME, Liao J, Pedley A, Dorr MB, Marcella S. Thirty-Day Readmissions in Hospitalized Patients Who Received Bezlotoxumab With Antibacterial Drug Treatment for Clostridium difficile Infection. Clin Infect Dis. 2017 Oct 1;65(7):1218-1221. doi: 10.1093/cid/cix523. PubMed 30060024 ↗
  • Birch T, Golan Y, Rizzardini G, Jensen E, Gabryelski L, Guris D, Dorr MB. Efficacy of bezlotoxumab based on timing of administration relative to start of antibacterial therapy for Clostridium difficile infection. J Antimicrob Chemother. 2018 Sep 1;73(9):2524-2528. doi: 10.1093/jac/dky182. PubMed 29788418 ↗
  • Gerding DN, Kelly CP, Rahav G, Lee C, Dubberke ER, Kumar PN, Yacyshyn B, Kao D, Eves K, Ellison MC, Hanson ME, Guris D, Dorr MB. Bezlotoxumab for Prevention of Recurrent Clostridium difficile Infection in Patients at Increased Risk for Recurrence. Clin Infect Dis. 2018 Aug 16;67(5):649-656. doi: 10.1093/cid/ciy171. PubMed 29538686 ↗
  • Wilcox MH, Gerding DN, Poxton IR, Kelly C, Nathan R, Birch T, Cornely OA, Rahav G, Bouza E, Lee C, Jenkin G, Jensen W, Kim YS, Yoshida J, Gabryelski L, Pedley A, Eves K, Tipping R, Guris D, Kartsonis N, Dorr MB; MODIFY I and MODIFY II Investigators. Bezlotoxumab for Prevention of Recurrent Clostridium difficile Infection. N Engl J Med. 2017 Jan 26;376(4):305-317. doi: 10.1056/NEJMoa1602615. PubMed 28121498 ↗
  • Desai K, Gupta SB, Dubberke ER, Prabhu VS, Browne C, Mast TC. Epidemiological and economic burden of Clostridium difficile in the United States: estimates from a modeling approach. BMC Infect Dis. 2016 Jun 18;16:303. doi: 10.1186/s12879-016-1610-3. PubMed 27316794 ↗

Individual participant data

Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01241552
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Nov 16, 2010
Start date
Oct 10, 2011
Primary completion
Dec 9, 2014
Completion
Dec 9, 2014
Results posted
Dec 15, 2016
Last update
Sep 5, 2018

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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