PMID- 31372837 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20201001 IS - 2193-8229 (Print) IS - 2193-6382 (Electronic) IS - 2193-6382 (Linking) VI - 8 IP - 3 DP - 2019 Sep TI - Telavancin in Hospital-Acquired and Ventilator-Associated Pneumonia (HAP/VAP) Caused by Staphylococcus aureus: Post Hoc Analysis of 2 Randomized, Controlled Trials. PG - 445-452 LID - 10.1007/s40121-019-0255-0 [doi] AB - INTRODUCTION: The efficacy and safety of telavancin versus vancomycin in microbiologically evaluable patients with hospital-acquired or ventilator-associated pneumonia (HAP/VAP) caused by Staphylococcus aureus with vancomycin minimum inhibitory concentration (MIC) >/= 1.0 microg/mL was analyzed using data derived from previously reported Assessment of Telavancin for Treatment of Hospital-Acquired Pneumonia (ATTAIN) trials. METHODS: This post hoc subgroup analysis of two randomized, double-blind, comparator-controlled, parallel-group phase 3 trials conducted at 274 sites in 38 countries included 194 microbiologically evaluable patients with HAP/VAP caused by monomicrobial S. aureus with vancomycin MIC >/= 1.0 microg/mL. Patients received intravenous telavancin (10 mg/kg every 24 h) or intravenous vancomycin (1 g every 12 h with site-specific modifications) for 7-21 days. Efficacy was assessed by clinical cure, defined as improvement or non-progression of radiographic findings at end of treatment and resolution of pneumonia signs and symptoms at follow-up/test-of-cure visits, and survival 28 days post-randomization. Safety was assessed from categorical shifts in creatinine clearance during therapy and adverse events (AEs). RESULTS: Clinical cure rates were numerically greater following telavancin versus vancomycin treatment overall (85.4% vs. 74.3%; treatment difference [95% confidence interval (CI)], 11.1% [- 0.002%, 22.2%]) and in patients aged >/= 65 years (81.6% vs. 66.2%; treatment difference [95% CI], 15.5% [- 0.9%, 30.2%]) patients with VAP (92.3% vs. 47.6%; treatment difference [95% CI], 44.7% [18.1%, 64.9%]), and patients with baseline Acute Physiology And Chronic Health Evaluation II score >/= 20 (71.4% vs. 55.6%; treatment difference [95% CI], 15.9% [- 11.7%, 40.5%]). Renal function declined in 7 (7.9%) patients receiving telavancin and 6 (5.7%) patients receiving vancomycin. Survival proportion was numerically higher (85.2% vs. 80.2%; treatment difference [95% CI], 5.0% [- 5.8%, 15.8%]) and AEs were comparable in patients treated with telavancin versus vancomycin. CONCLUSION: Telavancin is an alternative to vancomycin for HAP/VAP caused by S. aureus with vancomycin MIC >/= 1 microg/mL. FUNDING: Theravance Biopharma R&D, Inc., South San Francisco, CA, USA. FAU - Niederman, Michael S AU - Niederman MS AD - Division of Pulmonary and Critical Care Medicine, Weill Cornell Medicine, New York, NY, USA. FAU - Lee, Patrick C AU - Lee PC AD - Department of Surgery, Baystate Medical Center, Springfield, MA, USA. FAU - Barriere, Steven L AU - Barriere SL AD - Theravance Biopharma US, Inc., South San Francisco, CA, USA. FAU - Barnes, Chris N AU - Barnes CN AD - Theravance Biopharma US, Inc., South San Francisco, CA, USA. cbarnes@sprucebiosicences.com. FAU - Castaneda-Ruiz, Bibiana AU - Castaneda-Ruiz B AD - Theravance Biopharma US, Inc., South San Francisco, CA, USA. LA - eng PT - Journal Article DEP - 20190801 PL - New Zealand TA - Infect Dis Ther JT - Infectious diseases and therapy JID - 101634499 PMC - PMC6702499 OTO - NOTNLM OT - Hospital-acquired pneumonia OT - MRSA OT - Staphylococcus aureus OT - Telavancin OT - Vancomycin OT - Ventilator-associated pneumonia EDAT- 2019/08/03 06:00 MHDA- 2019/08/03 06:01 PMCR- 2019/08/01 CRDT- 2019/08/03 06:00 PHST- 2019/04/18 00:00 [received] PHST- 2019/08/03 06:00 [pubmed] PHST- 2019/08/03 06:01 [medline] PHST- 2019/08/03 06:00 [entrez] PHST- 2019/08/01 00:00 [pmc-release] AID - 10.1007/s40121-019-0255-0 [pii] AID - 255 [pii] AID - 10.1007/s40121-019-0255-0 [doi] PST - ppublish SO - Infect Dis Ther. 2019 Sep;8(3):445-452. doi: 10.1007/s40121-019-0255-0. Epub 2019 Aug 1.