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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Clostridium Difficile Infection

Intervention: MK-3415 (Biological); MK-6072 (Biological); MK-3415A (Biological); Placebo (Biological); SOC (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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.

Clinical Details

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of the Efficacy, Safety, and Tolerability of a Single Infusion of MK-3415 (Human Monoclonal Antibody to Clostridium Difficile Toxin A), MK-6072 (Human Monoclonal Antibody to Clostridium Difficile Toxin B), and MK-3415A (Human Monoclonal Antibodies to Clostridium Difficile Toxin A and Toxin B) in Patients Receiving Antibiotic Therapy for Clostridium Difficile Infection (MODIFY I)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of participants with Clostridium difficile infection (CDI) recurrence

Secondary outcome:

Number of participants with Global Cure

Number of participants with CDI recurrence in those with clinical cure of the initial CDI episode

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 (Imodiumâ„¢) or diphenoxylate hydrochloride/atropine sulfate (LOMOTILâ„¢), 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.

Locations and Contacts

Additional Information

Starting date: October 2011
Last updated: February 5, 2015

Page last updated: August 20, 2015

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