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Imipenem, cilastatin, relebactam

(Recarbrio®)

Imipenem, cilastatin, relebactam

Drug updated on 10/29/2024

Dosage FormInjection (intravenous; 1.25 g/vial)
Drug ClassPenem 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.

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Summary
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  • 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% 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 imipenem/cilastatin/relebactam (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 imipenem/cilastatin/relebactam (ICR) specifically focused on patients with complicated urinary tract infections (cUTIs); this trial was noted for its contribution to heterogeneity in microbiological response, suggesting population-specific variations in effectiveness.