Clinical and microbiological outcomes, by causative pathogen, in the ASPECT-NP randomized, controlled, Phase 3 trial comparing ceftolozane/tazobactam and meropenem for treatment of hospital-acquired/ventilator-associated bacterial pneumonia
| العنوان: | Clinical and microbiological outcomes, by causative pathogen, in the ASPECT-NP randomized, controlled, Phase 3 trial comparing ceftolozane/tazobactam and meropenem for treatment of hospital-acquired/ventilator-associated bacterial pneumonia |
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| المؤلفون: | Ignacio, Martin-Loeches, Jean-François, Timsit, Marin H, Kollef, Richard G, Wunderink, Nobuaki, Shime, Martin, Nováček, Ülo, Kivistik, Álvaro, Réa-Neto, Christopher J, Bruno, Jennifer A, Huntington, Gina, Lin, Erin H, Jensen, Mary, Motyl, Brian, Yu, Davis, Gates, Joan R, Butterton, Elizabeth G, Rhee |
| المصدر: | J Antimicrob Chemother |
| بيانات النشر: | Oxford University Press (OUP), 2022. |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Pharmacology, Microbiology (medical), Tazobactam, Ventilators, Mechanical, Meropenem, Microbial Sensitivity Tests, Hospitals, Anti-Bacterial Agents, Cephalosporins, Infectious Diseases, Pseudomonas aeruginosa, Pneumonia, Bacterial, Humans, Pharmacology (medical), Prospective Studies, Original Research |
| الوصف: | Objectives In the ASPECT-NP trial, ceftolozane/tazobactam was non-inferior to meropenem for treating nosocomial pneumonia; efficacy outcomes by causative pathogen were to be evaluated. Methods Mechanically ventilated participants with hospital-acquired/ventilator-associated bacterial pneumonia were randomized to 3 g ceftolozane/tazobactam (2 g ceftolozane/1 g tazobactam) q8h or 1 g meropenem q8h. Lower respiratory tract (LRT) cultures were obtained ≤36 h before first dose; pathogen identification and susceptibility were confirmed at a central laboratory. Prospective secondary per-pathogen endpoints included 28 day all-cause mortality (ACM), and clinical and microbiological response at test of cure (7–14 days after the end of therapy) in the microbiological ITT (mITT) population. Results The mITT population comprised 511 participants (264 ceftolozane/tazobactam, 247 meropenem). Baseline LRT pathogens included Klebsiella pneumoniae (34.6%), Pseudomonas aeruginosa (25.0%) and Escherichia coli (18.2%). Among baseline Enterobacterales isolates, 171/456 (37.5%) were ESBL positive. For Gram-negative baseline LRT pathogens, susceptibility rates were 87.0% for ceftolozane/tazobactam and 93.3% for meropenem. For Gram-negative pathogens, 28 day ACM [52/259 (20.1%) and 62/240 (25.8%)], clinical cure rates [157/259 (60.6%) and 137/240 (57.1%)] and microbiological eradication rates [189/259 (73.0%) and 163/240 (67.9%)] were comparable with ceftolozane/tazobactam and meropenem, respectively. Per-pathogen microbiological eradication for Enterobacterales [145/195 (74.4%) and 129/185 (69.7%); 95% CI: −4.37 to 13.58], ESBL-producing Enterobacterales [56/84 (66.7%) and 52/73 (71.2%); 95% CI: −18.56 to 9.93] and P. aeruginosa [47/63 (74.6%) and 41/65 (63.1%); 95% CI: −4.51 to 19.38], respectively, were also comparable. Conclusions In mechanically ventilated participants with nosocomial pneumonia owing to Gram-negative pathogens, ceftolozane/tazobactam was comparable with meropenem for per-pathogen 28 day ACM and clinical and microbiological response. |
| تدمد: | 1460-2091 0305-7453 |
| DOI: | 10.1093/jac/dkab494 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ffab12e476c1f960bad5a063e8f565e9 https://doi.org/10.1093/jac/dkab494 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....ffab12e476c1f960bad5a063e8f565e9 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14602091 03057453 |
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| DOI: | 10.1093/jac/dkab494 |