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  5. Drug Trials Snapshots: XACDURO
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Drug Trials Snapshots: XACDURO

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the XACDURO Prescribing Information for all of the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

XACDURO (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use
Zac dur’ oh
Entasis Therapeutics, Inc.
Original Approval date: May 23, 2023

DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

XACDURO is an antibacterial drug to treat adults who have hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by specific bacteria called Acinetobacter baumannii-calcoaceticus complex. It should not be used to treat pneumonia, which is caused by other bacteria.

How is this drug used?

XACDURO is a drug administered by a health care professional directly into the bloodstream through a needle in the vein, known as an intravenous (IV) infusion. It is given every six hours.

Who participated in the clinical trials?

FDA approved XACDURO based on a trial (NCT03894046) of 177 hospitalized adult patients with pneumonia caused by Acinetobacter baumannii-calcoaceticus complex. The trial included patients from China, Greece, Hungary, Israel, Peru, Russia, Taiwan, and other countries. There was one patient in the trial from North America.

How were the trials designed?

XACDURO was evaluated in one clinical trial that compared XACDURO to colistin in the treatment of hospitalized adults with pneumonia caused by Acinetobacter baumannii-calcoaceticus complex infections. Both treatments were given intravenously for up to 14 days. Both groups also received an additional antibacterial drug, imipenem/cilastatin, to treat additional bacteria other than Acinetobacter baumannii-calcoaceticus complex that could potentially cause HABP/VABP. Although the clinical trial investigator knew the identity of the drugs, neither the patients nor the independent assessor knew which drugs were given until after the trial was completed. The benefit of XACDURO was measured by deaths from all causes within 28 days of treatment in patients with a confirmed infection with carbapenem-resistant A. baumannii.

DEMOGRAPHICS SNAPSHOT

Figure 1 summarizes how many males and females were enrolled in the clinical trial.

Figure 1. Demographics by Sex

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 95 (74%) male patients and 33 (26%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 2 summarizes the percentage of patients by race in the clinical trial, used to evaluate the side effects of XACDURO.

Figure 2. Baseline Demographics by Race

Pie chart summarizing how many White, Black or African American, Asian, American Indian or Alaska Native, and other patients were in the clinical trial. In total, 63 (49.2%) White patients, 1 (0.8%) Black or African American patient, 57 (44.5%) Asian patients, 6 (4.7%) American Indian or Alaska Native patients, and 1 (0.8%) other patient participated in the clinical trial.

Source: Adapted from FDA Review

Figure 3 summarizes how many patients by age were in the clinical trial.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many patients by age were in the clinical trial. In total, 67 (52%) patients younger than 65 years of age, 28 (22%) patients between 65 and 75 years of age, and 33 (26%) patients older than 75 years of age participated in the clinical trial.

Source: Adapted from FDA Review

Figure 4 summarizes how many patients by ethnicity were in the clinical trial.

Figure 4. Baseline Demographics by Ethnicity

Pie chart summarizing how many Hispanic, not Hispanic, and not reported patients were in the clinical trial. In total, 18 (14.1%) Hispanic or Latino patients, 109 (85.2%) not Hispanic or Latino patients, and 1 (0.8%) not reported patient participated in the clinical trial.

Source: Adapted from FDA Review

What are the benefits of this drug?

In patients with pneumonia caused by Acinetobacter bacteria, the use of XACDURO resulted in survival similar to colistin (an antibacterial drug to treat Acinetobacter infections). Of those who received XACDURO, 19% died compared to 32% treated with colistin.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: Clinical studies of XACDURO did not include enough patients to determine whether the drug works differently in males and females.
  • Race: The majority of patients were White. The number of patients in other races were limited. Differences in how well the drug worked among races could not be determined.
  • Age: Clinical studies of XACDURO did not include enough patients aged 65 years and older to determine whether they respond differently than younger patients.

What are the possible side effects?

XACDURO may cause serious and life-threatening allergic reactions and severe diarrhea caused by Clostridioides difficile. Common side effects that were associated with the use of XACDURO include liver test abnormalities, diarrhea, anemia, and hypokalemia (low potassium).

Were there any differences in side effects of the clinical trials among sex, race, and age?

  • Sex: The occurrence of side effects was similar between males and females.
  • Race: The majority of the patients were White and Asian. The number of patients in other races was limited. Differences in side effects among races could not be determined.
  • Age: The occurrence of side effects was similar between patients younger and older than 65 years of age.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

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