Drug updated on 12/11/2024
Dosage Form | Injection (intravenous; 1.25 g/vial) |
Drug Class | Penem antibacterials, renal dehydropeptidase inhibitors, betalactamase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP)
- Indicated in patients 18 years of age and older for the treatment of complicated urinary tract infections, including pyelonephritis (cUTI) in patients who have limited or no alternative treatment options
- Indicated in patients 18 years of age and older for the treatment of complicated intra-abdominal infections (cIAI) in patients who have limited or no alternative treatment options.
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- The pooled risk ratio (RR) for clinical cure with novel carbapenem-beta-lactamase inhibitor combinations, including imipenem/cilastatin/relebactam (ICR), was 1.11 (95% confidence interval (CI): 0.98-1.26) compared to control groups, indicating a potential benefit in achieving clinical cure.
- For microbiological eradication, the pooled RR was 0.98 (95% CI: 0.82-1.16), with sensitivity analysis revealing that the Phase II trial of ICR in complicated urinary tract infections (cUTIs) contributed significantly to the heterogeneity of the response data.
- The all-cause mortality pooled RR was 0.90 (95% CI: 0.49-0.94) for novel carbapenem-beta-lactamase inhibitor combinations, with a 28-day mortality pooled RR of 0.68 (95% CI: 0.49-0.94), suggesting improved survival rates in treated populations.
- The pooled RR for adverse events (AEs) from any cause was 0.98 (95% CI: 0.93-1.04), indicating that novel carbapenem-beta-lactamase inhibitor combinations, including ICR, were as tolerable as comparators.
- The pooled RR for serious adverse events (SAEs) was 1.01 (95% CI: 0.75-1.36), demonstrating no significant difference in the risk of SAEs between novel carbapenem-beta-lactamase inhibitor combinations and comparators.
- The studies included both healthy subjects and patients with pneumonia, while the Phase II trial of ICR specifically focused on patients with cUTIs; this trial was noted for its contribution to heterogeneity in microbiological response, suggesting population-specific variations in effectiveness.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Recarbrio (imipenem, cilastatin, relebactam) Prescribing Information. | 2022 | Merck & Co. Inc., Rahway, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
A Systematic Review of the Pharmacokinetics and Pharmacodynamics of Novel Beta-Lactams and Beta-Lactam with Beta-Lactamase Inhibitor Combinations for the Treatment of Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria | 2024 | International Journal of Antimicrobial Agents |
Efficacy and safety of novel carbapenem-beta-lactamase inhibitor combinations: Results from phase II and III trials | 2022 | Frontiers in Cellular and Infection Microbiology |