Telavancin for hospital-acquired pneumonia, including ventilator-associated pneumonia: the ATTAIN studies
Abstract number: O75
Rubinstein E., Corey G.R., Stryjewski M.E., Boucher H.W., Daly R.N., Genter F.C., Barriere S.L., Kitt M.M., Friedland H.D.
Objectives: Telavancin (TLV), a rapidly bactericidal, investigational, lipoglycopeptide with a multifunctional mechanism of action, is active against a broad range of clinically relevant Gram-positive bacteria, including meticillin-resistant Staphylococcus aureus (MRSA). MRSA is an important pathogen causing hospital-acquired pneumonia (HAP) worldwide. The ATTAIN studies were designed to compare the efficacy and safety of TLV with vancomycin (VAN) in patients with HAP, including patients with ventilator-associated pneumonia (VAP).
Methods: ATTAIN 1 & 2 were identical, multinational, multicentre, randomised, double-blind, Phase 3 studies. Patients 18 years with HAP caused by suspected or confirmed Gram-positive pathogens were randomised (1:1) to TLV 10 mg/kg IV every 24h or VAN 1 g IV every 12h (dosages adjusted per site-specific guidelines) for 721 days. The primary efficacy analysis in each study was non-inferiority of TLV compared with VAN in clinical cure rates in clinically evaluable (CE) patients. In addition, pooled analyses of the two studies were specified prospectively.
Results: A total of 1503 patients were randomised and treated (TLV=749, VAN=754); 658 of these patients were CE. In each study, the demographic and baseline characteristics were similar in the two treatment groups. Non-inferiority was achieved for both the All-treated (AT) and CE populations in each study as well as in the pooled analysis. The pooled clinical cure rates are displayed in the table below. Further, the clinical cure rate in CE patients with VAP was numerically higher in the TLV group (Table).
The overall incidence of adverse events (AEs) in both groups was comparable (82% for TLV, 81% for VAN). The most common AEs, which occurred at similar rates in both groups, were diarrhoea, constipation, and anaemia.
Conclusion: To our knowledge, ATTAIN was the largest programme conducted in patients with HAP due to Gram-positive bacteria. Data from the ATTAIN studies support the once-daily use of TLV for the treatment of Gram-positive HAP, including patients with VAP.
|Session name:||18th European Congress of Clinical Microbiology and Infectious Diseases|
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