The study of Bezlotoxumab (MK-6072) versus placebo in children with Clostridium Difficile (CDI) diarrhea
- Conditions
- Prevention of recurrent Clostridium difficile infection (CDI)MedDRA version: 20.0Level: LLTClassification code 10012748Term: Diarrhoea, Clostridium difficileSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2017-000070-11-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 192
1. At the time of screening, participant
A) has suspected or confirmed CDI, as evidenced by the following: 1. had a change in normal bowel habits for 2 or more calendar days with either watery diarrhea (for participants using diapers or other type of fecal collection device, Bristol Stool Scale types 6 or 7) or at least 6 UBMs (eg, takes shape of container, or Bristol Stool Scale types 5, 6, or 7) within a 48-hour period, and 2.produced a stool sample that has tested positive for toxigenic C. difficile according to local diagnostic criteria.
B) is receiving or is planning to receive a 10- to 21-day course of antibacterial drug treatment for CDI, which is defined as oral vancomycin, oral metronidazole, or oral fidaxomicin. Additionally, IV metronidazole may be given concurrently with oral vancomycin or oral fidaxomicin
2. At the time of randomization/ study infusion, participant: a)has a diagnosis of CDI confirmed by a diagnostic assay which detects the presence of C. difficile toxin in stool and b)is still receiving antibacterial drug treatment for CDI
3.Participant is of either sex and of any race, and =1 year to <18 years of age at the time of randomization
4. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
a)Not a woman of childbearing potential (WOCBP) as defined in the protocol OR b) A WOCBP who agrees to use any contraceptive method listed in the protocol from Day 1 through at least 12 weeks after the single infusion of study treatment.
5. The participant (or legally acceptable representative [LAR] if applicable) provides written informed consent/assent for the trial. The participant or LAR may also provide consent/assent for Future Biomedical Research (FBR). However the participant may participate in the main trial without participating in FBR
6. Participant must be able to adhere to the study visit schedules
7. Participant and/or parent or caregiver must be able to read, understand, and complete the daily diary
Are the trial subjects under 18? yes
Number of subjects for this age range: 192
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Participant has an uncontrolled chronic diarrheal illness such as, but not limited to, Crohn’s disease, ulcerative colitis, or with a condition such that their normal 24-hour bowel movement habit is 3 or more UBMs. Participants with a history of IBD who are controlled (ie, had no recent active diarrhea/UBMs prior to current CDI episode) may be enrolled if in the opinion of the investigator, the symptoms are more likely due to CDI than a flare of the IBD
2. Has a known hypersensitivity to bezlotoxumab, its active substance and/or any of its excipients
3. Participant for whom, at the time of randomization, the planned course of antibacterial drug treatment for CDI is longer than 21 days
4. Participant has received any treatment or procedure listed in the protocol within the indicated exclusion window
5. Participant has previously participated in this trial, has previously received bezlotoxumab, has received an experimental mAb against C. difficile toxin B, or has received a vaccine directed against C. difficile or its toxins
6. Participant has received an investigational trial 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 trial period
7. Participant is not expected to survive for 72 hours
8. Participant has any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant, would make it unlikely for the participant to complete the trial, or would confound the results of the trial
9. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method