The clinical detailed results of the new antibiotic combination of Mercadon to treat bacterial pneumonia in stage 3 were published.

On May 6th, U.Stime, Mercado released detailed results for a Phase 3 clinical trial (RESTORE-IMI 2) evaluating the efficacy and safety of adult patients with hospital acquired/ventilator-related bacterial pneumonia (HABP/VABP) of its new antibiotic portfolio, Recarbrio, in hospitalsThe results showed that Recarbrio showed statistically uneffective results in all-cause mortality and clinical response on the 28th day, compared to the main and primary secondary endpoints of the study, compared to the primary and primary secondary endpoints of the study, compared to the piperacillin/tazobactam, PIP/TAZThe results are consistent with a summary published at the 30th European Conference on Clinical Microbiology and Infectious Diseases (ECCMID)RESTORE-IMI 2 is a global, randomized, double-blind, non-performance Phase 3 clinical trialA total of 537 patients participated in the study, randomly assigned at a scale of 1:1, to receive Recarbrio (imipenem 500mg / cilastatin 500mg / relebactam 250mg) or PIP/TAZ (4000mg / tabartan 500mg) every 6 hours, an intravenous injection lasting 7 to 14 daysPatients in both groups were also given an open-label linamine (600mg) administration until the baseline culture no longer detected Methicillin-resistant Staphylococcus aureus (MRSA)The primary endpoint indicator was the cause-of-the-disease rate for 28 days, and the key secondary endpoint was the clinical response to early follow-up (7 to 14 days after completion of treatment)results showed that Recarbrio reached the primary and primary secondary endpoints of the studyThe data were based on a total cause-to-cause mortality rate of 15.9% (42/264) for patients in the Recarbrio treatment group on the 28th day, and 21.3% (57/267) in the PIP/TAZ treatment group (5.3% for adjusted treatment, with a 95% confidence interval of 5.3% and a 95% confidence interval of -11.9, 1.2)The clinical response of patients in the Recarbrio treatment group was good, at 60.9% (161/264) and 55.8% (149/267) in the PIP/TAZ group (5%, 95% CI: -3.2, 13.2)The overall incidence of adverse events (AE) was similar intwo treatment groups, with 84.9% in the Recarbrio group and 86.6% in the PIP/TAZ groupIn addition, the rate of treatment interruption due to any AE was similar in both groups, with 6% in the Recarbrio group and 8% in the PIP/TAZ groupTreatment discontinuity rates caused by drug-related AE were similar, with 2.3% in the Recarbrio group and 1.5% in the PIP/TAZ groupRecarbrio is a fixed-dose combination of relebactam, imipenem and cilastatin, an innovative beta-lactamase inhibitor, and imipenem is an approved beta-lactamide antibiotic, while cilastatin prevents imipenem from being broken down by the kidneysJuly 2019, Recarbrio received FDA approval for treatment in adult patients with complex urinary tract infections (cUTI) when treatment options are limited or no alternative treatment options, including treatment for reneusitis and complex intra-abdominal infections (cIAI) caused by susceptible gram-negative bacteria In February 2020, the FDA accepted Recarbrio's application for supplementary new drugs (sNDA) for adult patients with HABP/VABP and granted priority review, with a final decision scheduled for June 4, 2020 reference source: 1, Results of Phase 3 Trial Evaluating the Efficacy and Safety of Merck's RECARBRIO ™ (Imipenem, Cilastatin, and Relebactam) Versus Piperacillin and Tazobactam in Adult Patients with HABP/VABP Now Available 2, RESTORE-IMI 2: Imipenem/Cilastatin Relebactam Non-re-zon to Piperacillin/Tazobactam for P HAB/VABP