recurrence of Clostridium difficile infection (CDI) MedDRA version: 14.1 Level: PT Classification code 10054236 Term: Clostridium difficile infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Code: MK-3415
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: MK-3415
Other descriptive name: MK-3415
Concentration unit: mg/kg milligr
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant must be 18 years of age or older. 2. Participant has a diagnosis of CDI as defined by: a. Presence of diarrhea, as defined by passage of 3 or more loose stools in 24 or fewer hours, AND b. A positive stool test for toxigenic C. difficile. 3. 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. 4. 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) 5. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 800
Exclusion criteria
Exclusion criteria: 1. participant with an active chronic diarrheal illness such as, but not limited to, ulcerative colitis or Crohn's disease or with a condition that causes routine passage of loose stool (e.g., an ostomy). 2. Participant with a planned surgery for CDI within 24 hours. 3. 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. 4. Participant is breast-feeding or plans to breastfeed prior to the completion of the 12-week study period. 5. 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. 6. Participant has previously participated in this study or has previously received MK-3415 or MK-6072 (either alone or in combination). 7. Participant plans to donate blood and/or blood products within 6 months following the infusion. 8. 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. 9. Treatment with SOC therapy is planned for longer than 14 days 10. Participant has received cholestyramine, 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. 11. Participant plans to take antiperistaltic agents, 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. 12. Participant plans to take the probiotic Saccharomyces boulardii at any time following infusion (Day 1) and through the completion of the 12-week study period. 13. 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 during the 12- week study period. 14. Participant is not expected to survive for 72 hours. 15. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: assess whether MK-3415A given with the standard of care antibacterial therapy (SOC) relative to MK-3415, MK-6072, and placebo given with SOC reduces CDI recurrence over a period of 12 weeks and to evaluate the safety profile of a single infusion of monoclonal antibody therapy compared to placebo.;Secondary Objective: determine the proportion of patients with global cure (defined as clinical cure of the initial episode and no CDI recurrence through Week 12) in the treatment group receiving MK3415A given with SOC compared to the treatment group receiving placebo and SOC.;Primary end point(s): Proportion of patients with CDI recurrence.;Timepoint(s) of evaluation of this end point: Week 12 (Day 85±5 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients with global cure.;Timepoint(s) of evaluation of this end point: Week 12 (Day 85±5 days) | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Germany, India, Israel, Italy, Mexico, New Zealand, Portugal, Puerto Rico, South Africa, Spain, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Outcome results
None listed