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Tuesday, 02/23/2021 7:27:09 AM

Tuesday, February 23, 2021 7:27:09 AM

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Study Demonstrates Macrolide-Resistance in S. pneumoniae in the United States Exceeds 25 Percent Threshold Set in Current Community-Acquired Bacterial Pneumonia (Cabp) Treatment Guidelines

February 23 2021 - 07:00AM
GlobeNewswire Inc.

Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced the publication of a study documenting the high rates of macrolide-resistant Streptococcus pneumoniae throughout the United States. The study entitled, A Multicenter Evaluation of the Prevalence and Regional Variation in Macrolide Resistant S. pneumoniae in Ambulatory and Hospitalized Adult Patients in the U.S. was published this month in Open Forum Infectious Diseases (OFID), and demonstrated that macrolide resistance in S. pneumoniae is greater than 25 percent in most regions of the country and 39.5 percent overall. An accompanying editorial, authored by Daniel Musher, M.D., was also published in same issue of OFID.
The retrospective cohort study assessed 3,626 patients with a positive S. pneumoniae blood or respiratory culture evaluated between October 2018 and September 2019 at 329 hospitals in the BD Insights Research Database (Becton, Dickinson and Company, Franklin Lakes, NJ, US) across nine U.S. Census geographic regions. Macrolide resistance was observed in 47.3 percent of S. pneumoniae obtained from respiratory cultures, and 29.6 percent from blood cultures. While the overall rate of macrolide resistance was 39.5 percent, macrolide resistance in respiratory isolates was ≥25% in all regions of the U.S. In addition, higher rates of macrolide resistance were seen among ambulatory patients (45.3 percent) as compared with inpatients (37.8 percent).

Macrolide-resistant S. pneumoniae is designated as a serious public health threat according to the Centers for Disease Control and Prevention (CDC). S. pneumoniae is the leading cause of community-acquired bacterial pneumonia (CABP), a lung infection and the most common type of pneumonia that occurs outside of hospitals or other health care facilities. According to the CDC, S. pneumoniae causes 900,000 infections and 3,600 deaths annually. Joint guidance from the Infectious Diseases Society of America (IDSA)/American Thoracic Society (ATS) for the treatment of CABP recommend that macrolide antibiotics only be used if local pneumococcal resistance is less than 25 percent.

“The high rates of macrolide-resistant S. pneumoniae throughout the United States is the latest in mounting evidence for the need to combat the public health risks of antibiotic resistance,” said Kalvin C. Yu, MD, FIDSA and Medical Director at Becton Dickinson and Company. “Indiscriminate use of macrolides for viral conditions has been highlighted during COVID-19; the corollary here is clinicians now need to consider alternatives to macrolide monotherapy for suspected community-acquired pneumonia.”

“The findings from this study demonstrate the importance of contemporary, local epidemiology data to optimize the selection of empiric therapy for patients with CABP in accordance with 2019 guidelines issued by the IDSA/ATS,” said Jennifer Schranz, MD, Chief Medical Officer at Nabriva. “Based on current treatment guidelines, clinicians should consider alternatives to macrolide monotherapy for community-acquired pneumonia in the U.S. The study results also underscore the urgent need for innovative antibacterial agents with a novel mechanism of action against drug-resistant S. pneumoniae that offer a short-course, monotherapy treatment option.”

The full results of the study and related editorial commentary - Macrolides as empiric therapy for outpatients with pneumonia – are available online at OFID.


XENLETA is a first-in-class systemic pleuromutilin antibiotic for the intravenous (IV) and oral treatment of CABP in adults. XENLETA offers an effective and well tolerated empiric monotherapy for CABP with a treatment duration as short as five days and the potential to address the limitations of existing agents.

XENLETA has a novel mechanism of action that targets a binding site on bacteria that is different from existing antibiotics. It has been shown to result in no cross resistance to other antibiotic classes commonly prescribed for CABP and a low potential for the development of resistance. XENLETA is also convenient for patients being treated in the hospital, transitioning treatment out of the hospital or initiating treatment in the community.

About Nabriva Therapeutics plc

Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA® (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories.

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