| Related Articles |
Efficacy and Safety of Two Dose Regimens of Eravacycline Versus Ertapenem in Adult Community-Acquired Complicated Intra-abdominal Infections: Results of a Phase 2, Randomized, Double-Blind Study.
Antimicrob Agents Chemother. 2013 Dec 16;
Authors: Solomkin JS, Ramesh MK, Cesnauskas G, Novikovs N, Stefanova P, Sutcliffe JA, Walpole SM, Horn PT
Abstract
Eravacycline is a novel fluorocycline, highly active against Gram-positive and Gram-negative pathogens in vitro, including those with tetracycline and multi-drug resistance. This Phase 2, randomized, double-blind study was conducted to evaluate the efficacy and safety of two dose regimens of eravacycline compared with ertapenem in adult hospitalized patients with complicated intra-abdominal infections (cIAIs). Patients with confirmed cIAI requiring surgical or percutaneous intervention and antibacterial therapy were randomized (2:2:1) to receive eravacycline 1.5 mg/kg every 24 hours (q24h), eravacycline 1.0 mg/kg every 12 hours (q12h), or ertapenem 1 g (q24h) for a minimum of 4 days and maximum of 14 days. The primary efficacy endpoint was the clinical response in microbiologically evaluable (ME) patients at the test-of-cure (TOC) visit 10 to 14 days after the last dose of study drug therapy. Overall, 53 patients received eravacycline 1.5 mg/kg q24h; 56 received eravacycline 1.0 mg/kg q12h; and 30 received ertapenem. For the ME population, the clinical success rate at the TOC visit was 92.9% (39/42) in the eravacycline 1.5 mg/kg q24h group, 100% (41/41) in the eravacycline 1.0 mg/kg q12h group, and 92.3% (24/26) in the ertapenem group. The incidence of treatment-emergent adverse events was 35.8%, 28.6%, and 26.7%, respectively. Incidence rates of nausea and vomiting were low in both eravacycline groups. Both dose regimens of eravacycline were as efficacious as the comparator, ertapenem, in patients with cIAI and well tolerated. These results support the continued development of eravacycline for the treatment of serious infections, including those caused by drug-resistant Gram-negative pathogens. (This study has been registered at ClinicalTrials.gov under registration no. NCT01265784.).
PMID: 24342651 [PubMed - as supplied by publisher]