Efficacy, Safety and Tolerability of Cadazolid in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)
- Conditions
- Clostridium Difficile Infection
- Interventions
- Registration Number
- NCT01222702
- Lead Sponsor
- Actelion
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- Male or female
- At least 18 years of age
- With a diagnosis of Clostridium Difficile-associated diarrhea (CDAD): first occurrence or first recurrence.
Key
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vancomycin 125 mg Placebo-matching cadazolid Subjects received one vancomycin capsule (125 mg) four times daily and reconstituted placebo-matching cadazolid suspension twice daily for 10 days Cadazolid 250 mg Placebo-matching vancomycin Subjects received 250 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days Cadazolid 500 mg Placebo-matching vancomycin Subjects received 500 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days Cadazolid 1000 mg Placebo-matching vancomycin Subjects received 1000 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days Cadazolid 250 mg Cadazolid Subjects received 250 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days Vancomycin 125 mg Vancomycin Subjects received one vancomycin capsule (125 mg) four times daily and reconstituted placebo-matching cadazolid suspension twice daily for 10 days Cadazolid 500 mg Cadazolid Subjects received 500 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days Cadazolid 1000 mg Cadazolid Subjects received 1000 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
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.
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
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
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
Trial Locations
- Locations (23)
Clinical Investigative Site 6601
🇨🇦Montreal, Quebec, Canada
Clinical Investigative Site 6935
🇺🇸Marietta, Georgia, United States
Clinical Investigative Site 6702
🇸🇪Orebro, Sweden
Clinical Investigative Site 6632
🇩🇪Koln, Germany
Clinical Investigative Site 6902
🇺🇸Newark, Delaware, United States
Clinical Investigative Site 6634
🇩🇪Ulm, Germany
Clinical Investigative Site 6801
🇬🇧Blackpool, United Kingdom
Clinical Investigative Site 6804
🇬🇧York, United Kingdom
Clinical Ivestigative Site 6602
🇨🇦Calgary, Canada
Clinical Investigative Site 6930
🇺🇸Decatur, Georgia, United States
Clinical Investigative Site 6915
🇺🇸Idaho Falls, Idaho, United States
Clinical Investigative Site 6917
🇺🇸Boston, Massachusetts, United States
Clinical Investigative Site 6605
🇨🇦Victoria, British Columbia, Canada
Clinical Investigative Site 6936
🇺🇸Royal Oak, Michigan, United States
Clinical Investigative Site 6903
🇺🇸Columbus, Ohio, United States
Clinical Investigative Site 6606
🇨🇦Sherbrooke, Quebec, Canada
Clinical Investigative Site 6914
🇺🇸Houston, Texas, United States
Clinical Investigative Site 6938
🇺🇸Orlando, Florida, United States
Clinical Investigative Site 6919
🇺🇸Jacksonville, Florida, United States
Clinical Investigative Site 6906
🇺🇸Chicago, Illinois, United States
Clinical Investigative Site 6633
🇩🇪Regensburg, Germany
Clinical Investigative Site 6734
🇮🇹Busto Arsizio, Italy
Clinical Investigative Site 6735
🇮🇹Modena, Italy