Novel gel reduces nasal S. aureus burden
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Key takeaways:
- XF-73 nasal gel was effective in significantly reducing nasal Staphylococcus aureus burden.
- No local reactions at the application site or changes in sense of smell were reported after treatment with XF-73.
An exeporfinium chloride nasal gel called XF-73 was safe for patients and effectively decreased the burden of nasal Staphylococcus aureus, which lessens the risk of surgical site infections, researchers found.
“Staphylococcus aureus is the most common organism associated with surgical site infections (SSIs),” Julie E. Mangino, MD, professor of internal medicine at The Ohio State University, told Healio, adding that SSIs are the most costly of all health care-associated infections and are responsible for approximately $3.5 billion to $10 billion in U.S. health care costs annually.
According to Mangino, postoperative SSIs cause significant morbidity for patients and often require IV or oral antibiotics for prolonged durations, based on the site of infection.
If the SSI is in the bone/sternum or deep tissues of the mediastinum (ie, after cardiac surgery), for example, multiple procedures may be required, with the potential for follow-up appointments with surgeons, infectious diseases doctors, weekly laboratory monitoring and additional imaging.
“Whatever ‘processes’ can be done by the patient and surgeon to prevent an SSI is crucial to minimize the SSI risk,” Mangino said.
Currently, the most frequently prescribed agent for preventing SSI is mupirocin, which, Mangino explained, is applied multiple times each day for up to 7 days before surgery.
“The beauty of XF-73” — an exeporfinium chloride nasal gel — “is that it is very effective and works very quickly, which means that it can be applied to the anterior nostrils within 24 hours of surgery,” she said. “So, if for example, clinicians believe a patient needs to go to surgery tomorrow, decolonization can be started that same day and can be completed to minimize the SSI risk.”
To assess the safety and efficacy of XF-73, Mangino and colleagues conducted a phase 2, double-blind, randomized controlled trial of 83 adult patients scheduled to undergo open-chest cardiac surgery between Aug. 29, 2019, and March 29, 2021.
According to the study, patients were randomly assigned 1:1 to receive XF-73 or a placebo, with additional perioperative antibiotic use and preoperative antiseptic skin decolonization being left up to each facility’s standard of care.
Either treatment option was placed in the anterior nostrils of the patients four times within 24 hours before surgery and once before leaving the operating room. Before the fourth dose, swabs were performed and collected to assess for nasal S. aureus in the patients’ nostrils.
At the start of the study, baseline nasal S. aureus log10 CFU/mL were similar in both groups of patients. After three applications of treatment, the researchers saw a significant decrease in nasal S. aureus in the XF-73 group vs. placebo (2.842 log10 CFU/mL vs. 0.469 log10 CFU/mL; 95% CI, –2.7 to –1.5).
This decrease observed in the XF-73 group intensified within an hour of incision closure, with a mean difference of 2.2 log10 CFU/mL (95% CI, 2.7 to 1.6).
After assessing the percentage of patients with zero nasal S. aureus or a 2 log10 CFU/Ml or more reduction, they found that 83.7% of patients treated with XF-73 met this measurement within an hour of surgery vs. only 25% in the placebo group.
Additionally, the study showed that there were no local reactions at the application site or any changes in patients’ sense of smell after treatment with XF-73. There were also no SSIs reported in either patient group.
“XF-73 nasal gel is safe and efficacious in significantly reducing the nasal S. aureus burden. It works extremely fast and thus requires a rather short preoperative dosing schedule to attain this goal,” Mangino said.
She added that a larger, phase 3 study is being planned with XF-73.
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