Clostridium Difficile Infection
Conditions
Keywords
CDIFF, CDAD, CDI, Clostridium difficile infection
Brief summary
Cadazolid is a new antibiotic developed for the treatment of Clostridiun difficile associated diarrhea (CDAD), also known as Clostridium Difficile Infection (CDI). The purpose of the study was to evaluate the efficacy and safety of different doses of cadazolid in order to find the dose of cadazolid to be used for further clinical development of the compound in subjects with CDAD.
Interventions
DRUGVancomycin
Vancomycin, provided as capsules (125 mg) for oral administration
DRUGPlacebo-matching cadazolid
Placebo of cadazolid powder for oral suspension
DRUGPlacebo-matching vancomycin
Placebo of vancomycin capsules
DRUGCadazolid
Cadazolid, provided as powder (250 mg, 500 mg or 1000 mg) to be reconstituted as a suspension prior to oral administration
Sponsors
Actelion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male or female * At least 18 years of age * With a diagnosis of Clostridium Difficile-associated diarrhea (CDAD): first occurrence or first recurrence. Key
Exclusion criteria
* Concurrent life threatening condition. * Immuno-compromised subjects, concomittant immuno-suppresive treatment. * Concomitant antimicrobial treatment for CDAD. * Any circumstances or conditions, which, in the opinion of the investigator, would affect full participation of the subject in the study or compliance with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical cure rate at test-of-cure | Day 13 or 24-72 hours after end of treatment | Percentages of subjects with clinical cure are calculated, with clinical cure being defined as resolution of diarrhea with no further Clostridium Difficile-associated diarrhea (CDAD) treatment required at test-of-cure (TOC) visit. Resolution of diarrhea was defined as the occurrence of ≤ 2 semi-formed or formed stools during 24 h for at least 2 consecutive 24 h periods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events | From Day 1 to Day 14 | Percentage of subjects with any adverse events in each group from first study treatment intake up to 3 days after last study drug intake |
| Adverse events leading to premature discontinuation of study treatment | Up to Day 10 | Number of patients in each group who discontinued the study treatment due to an adverse event |
| Sustained cure rate | Between Day 13 and day 41 (within 4 weeks after end of treatment) | Percentages of subjects with sustained cure are calculated, with sustained cure being defined as clinical cure without CDAD recurrence up to the end of study |
| Time to resolution of diarrhea | From Day 1 up to Day 13 (or 24-72 hours after end of treatment) | Time to resolution of diarrhea was defined as the time (h) from the first intake of study treatment to the time (occurrence) of the first stool meeting the criteria for resolution of diarrhea up to test-of-cure. |
| Recurrence rate | Between Day 13 and Day 41 (within 4 weeks after end of treatment) | Percentages of subjects with recurrence are calculated, with recurrence being defined as the occurrence of diarrhea (\> 3 liquid or unformed stools within 24 h associated with positive C. difficile toxin A/B assay) within 4 weeks after EOT in subjects clinically cured (at test-of-cure). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Modified clinical cure rate | Day 13 or 24-72 hours after end of treatment | Percentage of subjects with modified clinical cure (mCC) is reported, with mCC defined as the occurrence of ≤ 3 liquid or unformed stools and any number of semi-formed or formed stools per day for at least two consecutive days, and thereafter maintained up to TOC visit. In addition, no concomitant medication active against CDAD received from the start of study treatment up to TOC |
Countries
Canada, Germany, Italy, Sweden, United Kingdom, United States
Outcome results
None listed