Date: 2014-10-08
Type of information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at IDWeek 2014, being held October 8-12 in Philadelphia
Company: Cubist Pharmaceuticals (USA - MA)
Product: fidaxomicin (Dificid®)
Action
mechanism: Dificid® (fidaxomicin) is indicated in adults (≥18 years of age) for treatment of Clostridium difficile-associated diarrhea (CDAD). To reduce the development of drug-resistant bacteria, Dificid® should be used only to treat infections that are proven or strongly suspected to be caused by Clostridium difficile. Fidaxomicin is not currently approved for use in pediatric patients.
Disease: Clostridium difficile-associated diarrhea (CDAD)
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On October 8, 2014, Cubist Pharmaceuticals announced it will present new data from a phase 1 safety and pharmacokinetic study of fidaxomicin in children with Clostridium difficile-associated diarrhea (CDAD) at IDWeek 2014, being held October 8-12 in Philadelphia. The presentation will provide early insight into the safety, pharmacokinetic profile and efficacy of fidaxomicin in children who have CDAD. This study of fidaxomicin enrolled 38 patients whose ages ranged from 11 months to 17 years, most of whom had complex underlying medical issues, including cancer (23.7%) and/or gastrointestinal disorders (78.9%). Adverse events observed in greater than two subjects included fever, vomiting, upper abdominal pain and C-difficile colitis. At least one adverse event was reported in 73.7% of patients. The majority of adverse events were categorized as mild (44.7%) or moderate (21.1%). Nine severe adverse events were observed during the course of the study and were not considered related to fidaxomicin. The pharmacokinetic profile seen in this study is similar to the profile shown in an adult population. Although not powered to assess efficacy, the clinical response observed in the study was 92.1%. The infections recurred in 28.6% of patients, all but one of whom had a history of recurrent CDAD.
