A Randomized, Double-blind, Multicenter Trial Comparing Efficacy and Safety of Imipenem/Cilastatin/Relebactam Versus Piperacillin/Tazobactam in Adults With Hospital-acquired or Ventilator-associated Bacterial Pneumonia (RESTORE-IMI 2 Study)
| Autor: | Nicholas A. Kartsonis, Antoine Roquilly, Robert W. Tipping, Luke F Chen, Aileen David-Wang, Richard G. Wunderink, Joan R. Butterton, Daniel Gonzalez, Jiejun Du, Munjal Patel, Keith S Kaye, Katherine Young, Ivan Titov, Michelle L Brown, Maria C Losada, Amanda Paschke, Helen W. Boucher, Matthew L. Rizk |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
0301 basic medicine Microbiology (medical) Tazobactam medicine.medical_specialty Imipenem 030106 microbiology Population mechanical ventilation 03 medical and health sciences 0302 clinical medicine Pseudomonas Internal medicine Multicenter trial polycyclic compounds medicine Humans 030212 general & internal medicine Online Only Articles carbapenem resistant education Aged Piperacillin Cross Infection education.field_of_study Ventilators Mechanical Cilastatin business.industry nosocomial pneumonia Healthcare-Associated Pneumonia Imipenem/cilastatin Pneumonia Ventilator-Associated Hospitals Anti-Bacterial Agents KPC AcademicSubjects/MED00290 Infectious Diseases Antimicrobial Resistance and Stewardship Piperacillin/tazobactam business Azabicyclo Compounds medicine.drug |
| Zdroj: | Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America |
| ISSN: | 1537-6591 1058-4838 0249-3764 |
| Popis: | Background Imipenem combined with the β-lactamase inhibitor relebactam has broad antibacterial activity, including against carbapenem-resistant gram-negative pathogens. We evaluated efficacy and safety of imipenem/cilastatin/relebactam in treating hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP). Methods This was a randomized, controlled, double-blind phase 3 trial. Adults with HABP/VABP were randomized 1:1 to imipenem/cilastatin/relebactam 500 mg/500 mg/250 mg or piperacillin/tazobactam 4 g/500 mg, intravenously every 6 hours for 7–14 days. The primary endpoint was day 28 all-cause mortality in the modified intent-to-treat (MITT) population (patients who received study therapy, excluding those with only gram-positive cocci at baseline). The key secondary endpoint was clinical response 7–14 days after completing therapy in the MITT population. Results Of 537 randomized patients (from 113 hospitals in 27 countries), the MITT population comprised 264 imipenem/cilastatin/relebactam and 267 piperacillin/tazobactam patients; 48.6% had ventilated HABP/VABP, 47.5% APACHE II score ≥15, 24.7% moderate/severe renal impairment, 42.9% were ≥65 years old, and 66.1% were in the intensive care unit. The most common baseline pathogens were Klebsiella pneumoniae (25.6%) and Pseudomonas aeruginosa (18.9%). Imipenem/cilastatin/relebactam was noninferior (P Imipenem/cilastatin/relebactam was noninferior to piperacillin/tazobactam for treating hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), with a comparable tolerability profile. Imipenem/cilastatin/relebactam is an efficacious treatment option for nosocomial pneumonia, including HABP/VABP in mechanically ventilated and critically ill, high-risk patients. |
| Databáze: | OpenAIRE |
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