A new study has found that imipenem-cilastatin-relebactam is a viable treatment option for critically ill patients with hospital-acquired or ventilator-associated pneumonia. The drug demonstrated non-inferiority to piperacillin-tazobactam in terms of 28-day all-cause mortality, clinical response rates, and microbiological response rates.
In a multinational phase 3 trial, imipenem-cilastatin-relebactam demonstrated noninferiority to piperacillin-tazobactam in treating critically ill patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), with a comparable safety profile.
This multinational phase 3 trial, conducted between September 2018 and July 2022, compared imipenem-cilastatin-relebactam with piperacillin-tazobactam for HABP and VABP to support its use across multiple countries. Overall, 270 patients with HABP or VABP (mean age, 57.6 years; 73.3% men) were randomly assigned to receive either intravenous imipenem-cilastatin-relebactam (500 mg/250 mg) or piperacillin-tazobactam (4000 mg/500 mg) every 6 hours over 30 minutes for 7-14 days. Both treatment groups included critically ill patients, with 54.5% and 55.1% of patients in the imipenem-cilastatin-relebactam and piperacillin-tazobactam groups, respectively, having an Acute Physiology and Chronic Health Evaluation II score ≥ 15. The primary outcome was the 28-day all-cause mortality; secondary outcomes included the rates of clinical and microbiological responses, as well as the incidence of adverse events.Imipenem-cilastatin-relebactam was noninferior to piperacillin-tazobactam in terms of 28-day all-cause mortality (adjusted difference, 5.2%; 95% CI, −1.5-12.4;At the end of treatment, the rates of a favorable clinical response were comparable between the imipenem-cilastatin-relebactam (71.6%) and piperacillin-tazobactam (68.4%) groups. After treatment, microbiological response rates were 48.8% in the imipenem-cilastatin-relebactam group, whereas the rates were 47.9% in the piperacillin-tazobactam group. The incidence of drug-related adverse events was similar across the treatment groups, with diarrhea, increased levels of alanine aminotransferase and aspartate aminotransferase, and abnormal hepatic function being the most common event
Imipenem-Cilastatin-Relebactam Piperacillin-Tazobactam Hospital-Acquired Bacterial Pneumonia Ventilator-Associated Bacterial Pneumonia Clinical Trials
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