The US Food and Drug Administration (FDA) yesterday approved the novel antibiotic Zevtera (ceftobiprole medocaril sodium for injection) for treating serious bacterial infections in adults and children.

The approval of the cephalosporin antibiotic is for three indications: (1) Staphylococcus aureus bacteremia (SAB), including right-sided infective endocarditis, in adults; (2) acute bacterial skin and skin-structure infection (ABSSSI) in adults; (3) and community-acquired bacterial pneumonia (CABP) in adults and children as young as 3 months.

"The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Zevtera will provide an additional treatment option for a number of serious bacterial infections," Peter Kim, MD, MS, director of the Division of Anti-Infectives in the FDA's Center for Drug Evaluation and Research, said in an agency press release.

Broad clinical utility

The approval was based on evidence from three phase 3 clinical trials. In the ERADICATE trial, Zevtera was found to be noninferior to daptomycin for overall treatment success at 70 days post-treatment in adults hospitalized with complicated SAB, including infections caused by methicillin-resistant S aureus. That result was significant, given the limited treatment options for SAB, which has a high mortality rate.

The TARGET trial demonstrated that Zevtera was noninferior to vancomycin plus aztreonam in terms of early clinical response in adults with ABSSSI. In a trial involving adults with CABP, treatment with Zevtera resulted in competitive clinical cure rates compared with ceftriaxone with optional linezolid.

The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Zevtera will provide an additional treatment option for a number of serious bacterial infections.

The approval for Zevtera in children with CABP was based on evidence from the adult trial plus ad a smaller trial that included 138 pediatric patients ages 3 months to less than 18 years.

The approval was granted to Swiss biopharmaceutical company Basilea Pharmaceutica. Prior to FDA approval, Zevtera was approved in several countries in Europe and elsewhere for treating adults with CABP and hospital-acquired pneumonia.

"This approval is a landmark for ceftobiprole and reflects its broad clinical utility," Basilea chief medical officer Marc Engelhardt, MD, said in a company press release.

A new study released ahead of the upcoming European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Barcelona, Spain, shows that transmission of pneumococcus was highest among older adults who had frequent contact with preschoolers and young school-aged children.

The authors of the small, community-based study say the findings suggest that pneumococcal vaccination in adults could be beneficial even in populations where children are vaccinated at high rates.

Substantially higher pneumococcal carriage 

To assess the risks for acquisition of Streptococcus pneumoniae among community-dwelling older adults, researchers from Yale School of Public Health designed a longitudinal study that included 183 adults age 60 and over (mean age 70.9 years) from 93 households with and without young children. Every 2 weeks over a 10-week period across two seasons (November 2020 to August 2021 and November 2021 to September 2022), they obtained saliva samples and questionnaires regarding social behaviors and health status, then used polymerase chain reaction tests to detect pneumococcal DNA.

Overall, 52 (4.8%) of 1,088 samples tested positive for pneumococcus, with 27 (22.3%) of 121 individuals colonized on at least one time point. Several study participants were colonized at multiple time points, including two who were colonized throughout the 10-week sampling period. 

The point prevalence of pneumococcal carriage was substantially higher among those who reported contact with children compared with those who reported no contact with children (10.0% vs 1.6%). In addition, 14.8% and 14.1% of participants who reported contact with children aged 5 years and under and those aged 5 to 9 years had pneumococcal carriage, compared with 8.3% of those who reported contact with children over age 10.

Although the numbers were small, participants who had contact with children daily or every few days had the highest prevalence of pneumococcal carriage (15.7% and 14.0%, respectively). There was no clear evidence of adult-to-adult transmission.

"This suggests that the main benefit of adult pneumococcal vaccination is to directly protect older adults who are exposed to children who may still carry and transmit some vaccine-type pneumococcal strains despite successful national childhood vaccination programs," lead study author Anne Wyllie, PhD, said in an ECCMID press release.

Global life expectancy increased by 6.2 years since 1990 in large part because of a reduction in infectious diseases, according to a study yesterday in The Lancet. The progress came from reducing deaths from diarrhea, lower respiratory infections, stroke, and heart disease, but has been slowed by the COVID-19 pandemic.  

The study compared 288 causes of death from 1990 to 2021 in 204 countries and territories.

A super-region comprising Southeast Asia, East Asia, and Oceania had a net life expectancy gain of 8.3 years from 1990 to 2021. The region also had some of the tightest COVID-19 restrictions, which helped limit deaths from the novel coronavirus. Eastern sub-Saharan Africa experienced the largest increase in life expectancy, 10.7 years.

Most of these gains were owing to control of diarrheal and enteric diseases. Improvements in managing diarrheal diseases increased life expectancy worldwide by 1.1 years from 1990 to 2021, the authors said. 

COVID-19 replaces stroke as second-leading cause of death

In those three decades, the leading causes of age-standardized deaths globally remained the same: ischemic heart disease, stroke, chronic obstructive pulmonary disease, and lower respiratory infections. 

COVID-19 replaced stroke as the second-leading age-standardized cause of death in 2021, however, with 94.0 deaths (95% uncertainty interval, 89.2 to 100.0) per 100,000 population. The largest reduction in life expectancy due to COVID-19 occurred in Latin America and the Caribbean (3.6 years). 

"As a leading cause of death, COVID-19 reduced life expectancy in 2 years nearly as much as reductions in communicable and [noncommunicable diseases] have improved it over decades," the authors concluded. 

As a leading cause of death, COVID-19 reduced life expectancy in 2 years .

"On one hand, we see countries’ monumental achievements in preventing deaths from diarrhea and stroke," said Liane Ong, PhD, a co-first author of the study and lead research scientist at the Institute for Health Metrics and Evaluation (IHME), in a press release from IHME. "At the same time, we see how much the COVID-19 pandemic has set us back."