Cumberland announces publication on results of clinical study of Vibativ

Cumberland Pharmaceuticals announced a new publication in Antimicrobial Agents and Chemotherapy detailing the results of the first clinical study investigating the safety and pharmacokinetics of Vibativ, or telavancin, injection in children 2 to 17 years of age. Vibativ is an intravenous antibiotic approved by the FDA for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia, or HABP/VABP, as well as complicated skin and skin structure infections, or cSSSIs, caused by certain gram-positive bacteria in adults2. This is the first reported study evaluating Vibativ in pediatric patients. This publication describes results of an open-label study aimed at characterizing a single 10 mg/kg dose of Vibativ in children 2 to 17 years of age who required systemic antibiotics for the treatment of a known or suspected bacterial infection. Of the 22 patients treated in the study, 14 were 12 to 17 years of age, 7 were 6 to 11 years of age and one was 2 years of age. The study found a single 10 mg/kg dose of Vibativ was safe with no serious adverse events or renal concerns. Drug exposure to Vibativ was lower in children compared with observations in adult patients.