Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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12 January 2015 |
Main ID: |
EUCTR2011-004590-90-AT |
Date of registration:
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12/01/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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not available
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Scientific title:
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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 - Effectiveness of MK-3415A Given with SOC vs. Placebo |
Date of first enrolment:
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16/02/2012 |
Target sample size:
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1600 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004590-90 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: adaptive design allows for discontinuation of suboptimal treatment arm(s)
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 4
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Phase:
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Countries of recruitment
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Australia
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Austria
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Belgium
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Brazil
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Canada
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Chile
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Colombia
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Czech Republic
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Denmark
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Finland
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Germany
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India
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Israel
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Italy
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Mexico
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New Zealand
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Portugal
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South Africa
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Susanne Zottl
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Address:
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Am Euro Platz 2
1120
Vienna
Austria |
Telephone:
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+43126044234 |
Email:
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susanne.zottl@merck.com |
Affiliation:
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Merck Sharp & Dohme GesmbH |
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Name:
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Susanne Zottl
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Address:
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Am Euro Platz 2
1120
Vienna
Austria |
Telephone:
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+43126044234 |
Email:
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susanne.zottl@merck.com |
Affiliation:
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Merck Sharp & Dohme GesmbH |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Participant must be 18 years of age or older.
2. 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 stool test for toxigenic C. difficile. from a stool samples collected no more than 7 days before the study infusion
3. Participant must be receiving or planning to receive 10-14 day course of 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: 1. Patient with an uncontrolled chronic diarrheal illness such as, but not limited to, uncontrolled ulcerative colitis or Crohn's disease or with a condition such that their normal 24–hour bowel movement habit is 3 or more loose stools as defined by the Bristol Stool Chart Types 5, 6, and/or 7. Patients with with a history of inflammatory bowel disease who are controlled may be enrolled if in the opinion of the investigator the symptoms are more likely due to CDI than a flare of the inflammatory bowel disease.
2. Patient with a planned surgery for CDI within 24 hours.
3. Patient 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. Patient is breast-feeding or plans to breastfeed prior to the completion of the 12-week study period.
5. A female patient who plans to donate ova prior to the completion of the 12-week study period, or a male patient who is planning to impregnate or provide sperm donation prior to the completion of the 12-Week study period.
6. Patient has previously participated in this study or, has previously received MK-3415 or MK-6072 (either alone or in combination).), has received a C. difficile vaccine, or has received any other experimental monoclonal antibody against C. difficile toxin A or B.
7. Patient plans to donate blood and/or blood products within 6 months following the infusion.
8. Patient 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. Patient has received more than 24 hour regimen of cholestyramine, cholestimide, 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. Patient plans to take medications to control diarrhea or which 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.
12. Patient 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.
13. Patient 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.
14. Patient is not expected to survive for 72 hours.
15. Patient has any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the patient participating in the study, would make it unlikely for the patient to complete the study, or would confound the results of the study.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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recurrence of Clostridium difficile infection (CDI) MedDRA version: 16.1
Level: PT
Classification code 10054236
Term: Clostridium difficile infection
System Organ Class: 10021881 - Infections and infestations
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Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
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Intervention(s)
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Product Name: Actoxumab (USAN name) Product Code: MK-3415 Pharmaceutical Form: Solution for injection INN or Proposed INN: pending CAS Number: 1245634-25-6 Current Sponsor code: MK-3415 Other descriptive name: Not applicable Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intravenous use
Product Name: Bezlotoxumab (USAN name), MDX-1388, CDB1 MK-6072, MDX-1388, CDB1 Product Code: MK-6072 Pharmaceutical Form: Solution for injection INN or Proposed INN: pending CAS Number: 1246264-45-8 Current Sponsor code: MK-6072 Other descriptive name: Not applicable Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intravenous use
Product Code: MK-3415A Pharmaceutical Form: Solution for infusion INN or Proposed INN: pending CAS Number: 1245634-25-6 Current Sponsor code: MK-3415 Other descriptive name: not applicable Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 10- INN or Proposed INN: pending CAS Number: 1246264-45-8 Current Sponsor code: MK-6072 Other descriptive name: not applicable Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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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.
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Primary end point(s): Proportion of patients with CDI recurrence.
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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.
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Timepoint(s) of evaluation of this end point: Week 12 (Day 85±5 days)
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Week 12 (Day 85±5 days)
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Secondary end point(s): Proportion of patients with global cure.
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Secondary ID(s)
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2011-004590-90-DE
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3415A-001
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Source(s) of Monetary Support
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Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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