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

 -  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.