New evidence in severe pneumonia: imipenem/ cilastatin/relebactam

R M Girón1, A Ibáñez, R M Gómez-Punter

  • 1Rosa Mª Girón, Servicio de Neumología, Hospital Universitario de la Princesa. Madrid. Spain. rmgiron@gmail.com.

Insights

Imipenem-relebactam (IMI/REL) showed non-inferiority to piperacillin-tazobactam (PIP/TAZ) for hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP), with similar safety profiles.

Area of Science:

  • Infectious Diseases
  • Clinical Pharmacology
  • Antimicrobial Resistance

Background:

  • Gram-negative bacterial infections, particularly hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP), pose significant treatment challenges due to antimicrobial resistance.
  • Beta-lactamase inhibitors are crucial in restoring the efficacy of beta-lactam antibiotics against resistant Gram-negative pathogens.
  • Imipenem-relebactam (IMI/REL) targets Gram-negative bacteria producing class A or C beta-lactamases.

Purpose of the Study:

  • To evaluate the efficacy and safety of imipenem-relebactam (IMI/REL) compared to piperacillin-tazobactam (PIP/TAZ) in patients with HAP and VAP.
  • To assess the non-inferiority of IMI/REL against PIP/TAZ regarding all-cause mortality at 28 days.

Main Methods:

  • Phase 3, double-blind, randomized clinical trial (RESTORE-IMI-2).
  • Comparison of IMI/REL versus PIP/TAZ in adult patients diagnosed with HAP or VAP.
  • Assessment of clinical response at the end of treatment (7-14 days) and safety through adverse event monitoring.

Main Results:

  • Non-inferiority of IMI/REL to PIP/TAZ in 28-day all-cause mortality (15.9% vs. 21.3%).
  • Similar favorable clinical response rates at end of treatment (61% for IMI/REL vs. 59.8% for PIP/TAZ).
  • Comparable rates of serious adverse effects (26.7% for IMI/REL vs. 32% for PIP/TAZ).

Conclusions:

  • Imipenem-relebactam (IMI/REL) is a viable therapeutic option for treating HAP and VAP.
  • The study demonstrated comparable efficacy and safety between IMI/REL and PIP/TAZ.
  • Recommended dosage: imipenem 500 mg, cilastatin 500 mg, and relebactam 250 mg every 6 hours via IV infusion over 30 minutes.

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