Date: 2013-09-10
Type of
information: update on patient enrollment
phase: 3
Announcement: results
Company: Actelion (Switzerland)
Product: cadazolid
Action
mechanism: antibiotic. Cadazolid is a chimeric antibiotic with structural elements of the oxazolidinone as well as the quinolone class of antibiotics. It is a strong inhibitor of Clostridium difficile protein synthesis leading to strong suppression of toxin and spore formation.
Disease: Clostridium difficile associated diarrhea
Therapeutic
area: Infectious diseases
Country: Argentina, Belgium, Brazil, Canada, Chile, Croatia, Czechia, Greece, Hungary, Israel, Republic of Korea, Romania,Slovakia,USA and Australia, Brazil, Canada, France, Germany,Italy, Netherlands, Peru, Poland, Romania, Spain, USA
Trial
details: IMPACT is an International Multi-center Program Assessing Cadazolid Treatment in patients suffering from Clostridium difficile-associated diarrhea (CDAD). The program comprises two Phase III studies comparing the efficacy and safety of cadazolid (250 mg administered orally twice daily for 10 days) versus vancomycin (125 mg administered orally four times daily for 10 days).
Latest
news:
- • On June 8, 2017, Actelion provided an update on the Phase III program IMPACT to investigate the efficacy and safety of its novel anti-infective cadazolid versus vancomycin in the treatment of Clostridium difficile-associated diarrhea (CDAD). In the pivotal program, IMPACT 1 met its primary endpoint, while the second study IMPACT 2 did not meet the primary endpoint. Cadazolid demonstrated an acceptable tolerability and safety profile in the IMPACT program.
- IMPACT 1 and 2 compared the efficacy and safety of cadazolid (250 mg administered orally twice daily for 10 days) versus vancomycin (125 mg administered orally four times daily for 10 days). A total of 1263 patients worldwide participated in the IMPACT program, which assessed as primary endpoint whether the clinical response after administration of cadazolid is non-inferior to vancomycin in patients with CDAD.
- The company will now work diligently to complete the analyses of the full study results and detailed results will be made available through scientific disclosure at upcoming congresses and in peer-reviewed publications.
- • On September 10, 2013, Actelion has announced that it will initiate a Phase III clinical development program to assess the efficacy and safety of cadazolid in patients with Clostridium difficile-associated diarrhea (CDAD).
- The Phase III program consists of two identical multi-center, randomized, double-blind studies comparing the efficacy and safety of cadazolid, versus vancomycin, in subjects with Clostridium difficile-associated diarrhea (CDAD). The program is designed to determine whether the clinical response after administration of cadazolid is non-inferior to vancomycin in patients with CDAD, and whether administration of cadazolid is superior to vancomycin in the sustained clinical response. It is expected to enroll more than 1\'250 patients worldwide, and is planned to commence enrollment in the fourth quarter of 2013. The results of these Phase III studies are expected to form the basis for regulatory submissions for marketing approval throughout the world.
Phase II results were presented last December.
Is
general: Yes
