Recarbrio for Resistant Pneumonia

✓ Medically reviewed | Published: | Evidence level: 1A
CDC reporting on antimicrobial resistance during COVID-19 highlights the importance of effective treatments for hospital infections. A September analysis of the RESTORE-IMI 2 trial adds evidence for imipenem-cilastatin-relebactam, marketed as Recarbrio, in selected patients with resistant bacterial pneumonia, although its small subgroup cannot establish superiority over alternative antibiotics.
📅 Published:
✓ Reviewed by iMedic Medical Editorial Team
📄 Pharmacology

Quick Facts

Original Trial Treated
535 adults
Imipenem-Nonsusceptible Subgroup
18 patients
Imipenem-Susceptible Subgroup
112 patients

Why does pandemic-era resistance matter for pneumonia treatment?

Quick answer: The pandemic exposed how hospital pressures and resistant bacteria can complicate treatment for patients who develop bacterial pneumonia.

The CDC reports that hospital-onset resistant infections and associated deaths increased by at least 15% between 2019 and 2020 across seven pathogens. Its review describes longer hospital stays, greater use of ventilators and catheters, and disruptions to infection prevention. These are historical findings, rather than newly measured October figures, but they explain the continuing need for effective hospital antibiotics. Antibiotics were also frequently prescribed for COVID-19 even though they cannot treat its viral cause. [CDC review](https://www.cdc.gov/antimicrobial-resistance/data-research/threats/COVID-19.html).

Recarbrio combines three components with different jobs. Imipenem disrupts bacterial cell-wall construction. Cilastatin slows imipenem's breakdown in the kidneys. Relebactam blocks certain bacterial enzymes that would otherwise undermine the antibiotic. This combination can restore activity against some bacteria that resist imipenem alone. Its FDA indications include hospital-acquired and ventilator-associated bacterial pneumonia caused by specified susceptible organisms. [FDA prescribing information](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212819s008lbl.pdf).

What do the RESTORE-IMI 2 results actually show?

Quick answer: The original trial supported Recarbrio for hospital pneumonia, while the recent subgroup analysis offers limited additional evidence for imipenem-nonsusceptible infections.

In the original randomized RESTORE-IMI 2 trial, 535 adults received treatment with either imipenem-cilastatin-relebactam or piperacillin-tazobactam. The combination met the study's noninferiority criteria for mortality and clinical response. That means it performed within the prespecified acceptable margin compared with the other treatment. It does not establish that Recarbrio is universally better, and the overall trial population was not restricted to infections resistant to imipenem. [RESTORE-IMI 2 trial](https://academic.oup.com/cid/article/73/11/e4539/5891450).

A subgroup analysis published September 15, 2026, examined Recarbrio recipients with different baseline susceptibility results. It included 18 patients whose bacteria were nonsusceptible to imipenem but susceptible to the combination, and 112 with imipenem-susceptible bacteria. Death from any cause by day 28 occurred in 22.2% and 18.8%, respectively. Both groups received the same treatment: this comparison cannot establish an advantage over another antibiotic. [Subgroup analysis](https://pubmed.ncbi.nlm.nih.gov/42743113/).

The small nonsusceptible subgroup leaves substantial uncertainty, and patients were not randomly assigned to their bacterial susceptibility category. All authors reported current or previous employment with Merck, the manufacturer. The findings add context to the original trial but do not establish equivalent outcomes across resistance categories. [Study methods and disclosures](https://pubmed.ncbi.nlm.nih.gov/42743113/).

When might clinicians choose Recarbrio for resistant pneumonia?

Quick answer: Clinicians may consider it when the infecting bacterium is susceptible and its expected benefits fit the patient's infection, kidney function, and other medicines.

The Infectious Diseases Society of America includes imipenem-relebactam among preferred options for infections outside the urinary tract caused by difficult-to-treat resistant Pseudomonas aeruginosa. However, its current guidance favors ceftolozane-tazobactam specifically for pneumonia caused by that organism. There are no clinical trials directly comparing all these newer options. Treatment therefore depends on laboratory susceptibility results, the infection site, prior antibiotic exposure, and the patient's condition. Resistance can also emerge during treatment, making repeat testing relevant when infection persists or returns. [IDSA treatment guidance](https://www.idsociety.org/practice-guideline/amr-guidance).

Safety assessment remains essential. Recarbrio requires dose adjustment in adults with reduced kidney function. Its prescribing information warns about serious allergic reactions, seizures, and Clostridioides difficile-associated diarrhea. It can also lower valproic acid concentrations, potentially allowing breakthrough seizures; concurrent use should generally be avoided. These considerations make medication review and laboratory monitoring part of treatment selection. [FDA prescribing information](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212819s008lbl.pdf).

Frequently Asked Questions

No. It is an antibacterial medicine and does not treat SARS-CoV-2. A patient with COVID-19 may separately need antibiotics for a bacterial infection. [CDC review](https://www.cdc.gov/antimicrobial-resistance/data-research/threats/COVID-19.html).

Not necessarily. Relebactam can overcome some resistance mechanisms, so laboratories test susceptibility to the combination. Activity cannot be assumed from the organism's name alone. [FDA prescribing information](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212819s008lbl.pdf).

No. Different bacteria have different resistance mechanisms, and another antibiotic may be preferred. Selection should follow susceptibility testing and an assessment of clinical effectiveness and safety. [IDSA treatment guidance](https://www.idsociety.org/practice-guideline/amr-guidance).

References

  1. Centers for Disease Control and Prevention. [COVID-19 & Antimicrobial Resistance](https://www.cdc.gov/antimicrobial-resistance/data-research/threats/COVID-19.html). February 5, 2025.
  2. U.S. Food and Drug Administration. [Recarbrio prescribing information](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212819s008lbl.pdf). Revised December 2025.
  3. Clinical Infectious Diseases. [RESTORE-IMI 2 randomized trial of imipenem/cilastatin/relebactam versus piperacillin/tazobactam for hospital-acquired or ventilator-associated bacterial pneumonia](https://academic.oup.com/cid/article/73/11/e4539/5891450). 2021;73(11):e4539–e4548.
  4. Young K, et al. [RESTORE-IMI 2 subgroup analysis and molecular characterization of isolates](https://pubmed.ncbi.nlm.nih.gov/42743113/). PLOS ONE. September 15, 2026;21(9):e0357288. doi:10.1371/journal.pone.0357288.
  5. Infectious Diseases Society of America. [Guidance on the Treatment of Antimicrobial Resistant Gram-Negative Infections](https://www.idsociety.org/practice-guideline/amr-guidance). 2026.