BioCentury
ARTICLE | Clinical News

Plazomicin: Ph III CARE data

December 16, 2016 8:25 PM UTC

Top-line data from 37 patients with CRE infections in the microbiological modified intent-to-treat (mMITT) population of the first cohort of the open-label, international Phase III CARE trial showed that IV plazomicin plus meropenem or tigecycline led to a 23.5% rate of 28-day all-cause mortality or significant disease-related complications, the primary endpoint, vs. 50% for colistin plus meropenem or tigecycline. Plazomicin plus meropenem or tigecycline led to a 28-day all-cause mortality rate of 11.8% vs. 40% for colistin plus meropenem or tigecycline. Achaogen said no formal statistical hypothesis testing was performed due to the study's small size. Plazomicin was well tolerated. The trial’s first cohort enrolled 39 patients with bloodstream infections, hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) due to CRE. The trial’s second cohort enrolled 30 patients with bloodstream infections, HABP, VABP or complicated urinary tract infections (cUTIs) due to CRE who were not eligible for enrollment in the first cohort. Achaogen said it plans to include the CARE data in an NDA submission to FDA for plazomicin slated for 2H17...