Xacduro: How Does It Treat Resistant Hospital Pneumonia?

✓ Medically reviewed | Published: | Evidence level: 1A
CDC reporting on antimicrobial resistance during COVID-19 highlights the need for effective treatments for resistant hospital infections. Sulbactam-durlobactam, marketed as Xacduro, provides a targeted option for certain bacterial pneumonias, with current specialist guidance supporting its use alongside a carbapenem for invasive carbapenem-resistant Acinetobacter infections.
📅 Published:
✓ Reviewed by iMedic Medical Editorial Team
📄 Pharmacology

Quick Facts

FDA-Approved Age
18 years and older
Primary Efficacy Group
125 patients
Mortality Assessment
28 days

Why does Xacduro matter for antibiotic resistance after COVID-19?

Quick answer: Xacduro targets a difficult bacterial cause of hospital pneumonia within the broader resistance problem highlighted by the pandemic.

The CDC's review of COVID-19 and antimicrobial resistance describes how hospital pressures undermined infection prevention. Sicker patients, longer admissions, increased use of invasive devices, and staffing shortages contributed to conditions in which resistant infections could spread. Antibiotics were also frequently prescribed despite having no activity against the coronavirus itself. Carbapenem-resistant Acinetobacter was among the bacterial threats tracked in the agency's pandemic assessments. These findings concern historical pandemic periods and should not be interpreted as measurements of today's infection rates. [CDC pandemic resistance review](https://www.cdc.gov/antimicrobial-resistance/data-research/threats/covid-19.html).

Xacduro combines sulbactam, which kills susceptible Acinetobacter bacteria, with durlobactam, which protects sulbactam against certain bacterial enzymes that would otherwise disable it. The medicine is administered intravenously. Its FDA approval, granted in May 2023, covers adults with hospital-acquired or ventilator-associated bacterial pneumonia caused by susceptible members of the Acinetobacter baumannii-calcoaceticus complex. This is a specific treatment indication; the drug does not cover every organism responsible for hospital pneumonia. [FDA approval announcement](https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pneumonia-caused-certain-difficult-treat-bacteria).

What did the clinical trial establish about Xacduro?

Quick answer: The trial established noninferiority to colistin for 28-day mortality, while the numerical survival difference did not establish superiority.

In the pivotal randomized comparison, patients received either sulbactam-durlobactam or colistin, an older antibiotic. Both groups also received imipenem-cilastatin to address other potential bacterial causes of pneumonia. The primary efficacy analysis included 125 patients with confirmed carbapenem-resistant Acinetobacter infection. Death from any cause within 28 days occurred in 12 of 63 patients receiving sulbactam-durlobactam, approximately 19%, compared with 20 of 62 receiving colistin, approximately 32%. These results met the study's predefined criterion for noninferiority. [FDA trial summary](https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-xacduro).

Noninferiority means the new regimen met a prespecified standard for avoiding an unacceptable loss of effectiveness compared with its comparator. It does not automatically establish that the treatment saves more lives. The relatively small primary analysis and use of background antibiotics also matter: the study evaluated treatment regimens, so its findings cannot establish how sulbactam-durlobactam would perform alone. Nor does a comparison with colistin establish superiority over every other available option. [FDA trial design and results](https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-xacduro).

How do specialists decide when to use sulbactam-durlobactam?

Quick answer: Specialists assess whether Acinetobacter is causing an invasive infection, review susceptibility results, and select an appropriate combination regimen.

The Infectious Diseases Society of America's guidance published in July 2026 identifies sulbactam-durlobactam with imipenem or meropenem as the preferred approach for invasive carbapenem-resistant Acinetobacter infections. This professional guidance addresses a broader clinical question than the FDA's pneumonia indication. A positive respiratory culture alone does not establish infection: bacteria may be present without causing disease, particularly in ventilated patients. Clinicians therefore interpret laboratory findings alongside the patient's condition, and susceptibility testing helps establish whether the proposed drugs are active. [IDSA antimicrobial resistance guidance](https://www.idsociety.org/practice-guideline/amr-guidance/).

Treatment also requires safety assessment. The FDA identifies abnormal liver tests as the most common adverse reaction and warns about serious hypersensitivity reactions and Clostridioides difficile-associated diarrhea. Patients with a history of severe hypersensitivity to relevant beta-lactam antibiotics should not receive Xacduro. These considerations make specialist selection and monitoring central to its use in seriously ill patients. [FDA safety information](https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pneumonia-caused-certain-difficult-treat-bacteria).

Frequently Asked Questions

No. It is an antibacterial treatment and does not act against SARS-CoV-2. A patient with COVID-19 would need a separate bacterial infection warranting antibiotic treatment. [CDC](https://www.cdc.gov/antimicrobial-resistance/data-research/threats/covid-19.html).

No. The organism can colonize the respiratory tract without causing an active infection. Specialists assess the clinical findings before deciding whether targeted treatment is warranted. [IDSA guidance](https://www.idsociety.org/practice-guideline/amr-guidance/).

Xacduro is administered by intravenous infusion by a healthcare professional; it is not an oral medicine. Its approved use concerns specific hospital-acquired or ventilator-associated bacterial pneumonias. [FDA drug overview](https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-xacduro).

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. [FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria](https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pneumonia-caused-certain-difficult-treat-bacteria). May 23, 2023.
  3. U.S. Food and Drug Administration. [Drug Trials Snapshots: XACDURO](https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-xacduro). Original approval: May 23, 2023.
  4. Infectious Diseases Society of America. [Guidance on the Treatment of Antimicrobial Resistant Gram-Negative Infections](https://www.idsociety.org/practice-guideline/amr-guidance/). July 30, 2026.