Clostridioides Difficile Infection
Conditions
Keywords
Clostridioides difficile infection (CDI), ridinilazole, Adolescents, vancomycin, C. Diff, Clostridium difficile, Diarrhea, Infection, Pediatric
Brief summary
Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.
Interventions
DRUGRidinilazole
Ridinilazole 200mg dosed BID for 10 days.
DRUGVancomycin
Vancomycin 125mg dosed QID for 10 days.
Sponsors
Department of Health and Human Services
Summit Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Is aged 12 to \<18 years. * Has signs and symptoms of CDI including diarrhea such that in the Investigator's opinion CDI antimicrobial therapy is required, and the subject has tested positive for toxin A and/or B of C. difficile in the stool. Diarrhea is defined as ≥ 3 unformed bowel movements (UBMs) based on types 5, 6, 7 on the Bristol Stool Chart and diarrhea information is within 24 hours prior to randomization.
Exclusion criteria
* Has had more than the equivalent of 48 hours of dosing of antimicrobial treatment active against the current episode of CDI prior to randomization. * Has received ridinilazole or an investigational vaccine against C. difficile any time in the past, anti-toxic antibodies including bezlotoxumab within the past 6 months, or any other investigational medicinal product for treatment of CDI or fecal microbiota replacement therapy within the past 3 months. * Has a clinically relevant positive stool test for pathogens other than C. difficile, within 48 hours of randomization. * Has life-threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, toxic megacolon, or ileus. * Has had major GI surgery (e.g. significant bowel resection or pancreatectomy but not including appendectomy or cholecystectomy) within past 3 months or has the presence of a colostomy or ileostomy or has the likely requirement of an ostomy during the study. * Is receiving treatment that generally is associated with severe diarrhea, intractable vomiting, severe nausea, or inability to swallow that cannot be managed with antiemetics or antidiarrheals and that limits the ability to take oral medications. Cancer treatment that does not comprise ability to take study medication or cause severe diarrhea is allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Treatment-emergant Adverse Events | Until study completion (Day 100) | Safety was assessed using CTCAE v4. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ridinilazole Ridinilazole dosed BID and a comparator placebo dosed QID, to maintain blind, for 40 doses over 10 days.
Ridinilazole: Ridinilazole 200mg dosed BID for 10 days. | 1 |
| Vancomycin Vancomycin dosed QID and a Ridinilazole placebo dosed BID, to maintain blind, for 40 doses over 10 days.
Vancomycin: Vancomycin 125mg dosed QID for 10 days. | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Ridinilazole | Vancomycin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Incidence and Severity of Treatment-emergant Adverse Events
Safety was assessed using CTCAE v4.
Time frame: Until study completion (Day 100)
Population: No analysis was done for study outcome measures due to the fact that enrollment in the clinical trial did not reach the target number of subjects needed prior to study termination and was insufficient to produce statistically reliable results.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ridinilazole | Incidence and Severity of Treatment-emergant Adverse Events | 0 Participants |
| Vancomycin | Incidence and Severity of Treatment-emergant Adverse Events | 0 Participants |