Rapid diagnostic for neonatal sepsis receives CARB-X funding
CARB-X announced today that it is awarding Durham, North Carolina, biotech company Baebies Inc. up to $3.9 million to develop a rapid, easy-to-use diagnostic test for sepsis in newborns.
The diagnostic platform the company is developing uses digital microfluidics technology to test a small blood sample for bacterial infection and return results within 15 minutes. The test will also be able to determine the pathogen causing the infection and its antibiotic susceptibility, and measure host response markers unique to neonatal populations.
The project is currently in the feasibility phase of development, and if it meets project milestones, Baebies will be eligible for an additional $7.7 million from CARB-X (the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator).
Sepsis is the body’s overwhelming and often life-threatening response to an infection caused by bacteria. Neonatal sepsis kills up to 1.4 million infants worldwide each year, many in low- and middle-income nations with poor sanitation and limited healthcare resources.
“There is a critical need for a rapid and easy-to-use diagnostic platform for bacteremia—especially for the newborn population given the low circulating blood volume available for testing,” Baebies Inc. co-founder and President Vamsee Pamula, PhD, said in a CARB-X press release. “Through this CARB-X partnership, the development of blood culture and identification of bacteria on our FINDER platform not only enables clinicians to receive results fast, but also conserves the limited blood volume by maximizing the diagnostic yield.”
Apr 20 CARB-X press release
Studies show drop in fluoroquinolone use following FDA warning
Two new studies show that US use of oral fluoroquinolones dropped significantly after the Food and Drug Administration’s (FDA’s) 2016 safety warnings and label change.
Following a review of evidence linking fluoroquinolones to disabling and potentially permanent adverse effects involving tendons, muscles, joints, and the central nervous system, the FDA in May 2016 announced that it would remove indications for oral fluoroquinolones in acute, uncomplicate urinary tract infection (uUTI), acute sinusitis (AS), and acute exacerbation of chronic obstructive pulmonary disease (AE-COPD). The impact to date of this label change on fluoroquinolone prescribing has been unclear.
To see whether the label change resulted in decreases in oral fluoroquinolone use, researchers from the University of Florida analyzed data from a nationally representative sample of privately insured patients before and after the label change.
In results published yesterday in JAMA Internal Medicine, the researchers found that, prior to the label change, fluoroquinolones were used in 41.6% of uUTI episodes, 31.9% of AE-COPD episodes, and 8.3% AS episodes, and trends in monthly fluoroquinolone prevalence were nearly flat. The month of the label changes (July 2016), they observed an immediate significant reduction for uUTI (-7.2%), and a smaller reduction for AS (-1.2%) and AE-COPD (-2.6%). Monthly declines continued thereafter.
At the end of the study period, fluoroquinolones were used in 19.2% of uUTI episodes, 14.6% of AE-COPD episodes, and 2.9% of AS episodes—pointing to some opportunities for improvement, the researchers concluded.
Apr 19 JAMA Internal Med abstract
In the other study, published yesterday in Antimicrobial Agents and Chemotherapy, researchers with the University of Pittsburgh School of Medicine and the VA Pittsburgh Healthcare System examined national prescription audit databases from August 2014 through February 2020 to explore the same issue.
They found that, from 2015 through 2019, fluoroquinolone fills decreased from 35,616,786 (111.1 per 1,000 persons) to 21,100,050 (64.3/1,000 persons) annually, with an annual decline of 10.8%. Ciprofloxacin, levofloxacin, and moxifloxacin fills fell annually by 10.4%, 11.2%, and 17.7%, respectively. Fills dropped significantly in May 2016 and continued to decrease significantly through June 2018. During the baseline period (August 2014 through April 2016), there was no significant change in monthly fluoroquinolone fills.
“Taken together, our data demonstrate national progress toward achieving stewardship goals for outpatient fluoroquinolones, and attest to the impact of FDA safety warnings in limiting use of these drugs,” the authors wrote.
Apr 19 Antimicrob Agents Chemother abstract