Urgent Updates | December 1, 2022

Extended Follow-up of Microbiome Therapeutic SER-109 Through 24 Weeks for Recurrent Clostridioides difficile Infection (RCDI)  in a Randomized Clinical Trial
In a phase 3 trial (ECOSPOR III), SER-109, an investigational microbiome therapeutic composed of purified Firmicutes spores, was superior to placebo in reducing the rate of rCDI by week 8 (12% vs 40%; relative risk [RR], 0.32 [95% CI, 0.18-0.58]) SER-109 durably reduced rCDI rates and was well-tolerated through 24 weeks in patients with prevalent comorbidities. The benefit of SER-109 was evident as early as week 2, highlighting the need for rapid microbiome repair after completing standard-of-care antibiotics.
Full Access: JAMA

Most Global Bacterial Deaths in 2019 Linked to Five Pathogens
Overall, lower respiratory infections were responsible for 4 million deaths, bloodstream infections accounted for 2.91 million deaths, and peritoneal and intra-abdominal infections for 1.28 million deaths. The findings, published in The Lancet, point to Staphylococcus aureus as the leading cause of bacterial death in 135 countries and Streptococcus pneumoniae associated with the most deaths in children younger than 5 years. The three other most clinically significant pathogens were Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
Full Access:Lancet

Paxlovid for Treatment of Long Covid (STOP-PASC)
The purpose of this study is to compare whether being treated with Paxlovid (nirmatrelvir plus ritonavir) for 15 days works better than being treated with placebo (plus ritonavir) to reduce severe symptoms of Long Covid. Participants will have 5 planned visits to the study clinic over 18 weeks and will take the drug (or placebo) for the first 15 days. An exploratory sub-study will investigate the correlation of physical activity and biometric parameters from digital wearable devices with the subjective symptom severity and other patient-reported outcomes in the main study.
Full Access: Clinical Trials

FDA: Amoxicillin Shortage Hits U.S., How This Antibiotic Is Misused For Respiratory Illnesses
Since October 28, amoxicillin oral powder for suspension has been on the U.S. Food and Drug Administration’s (FDA’s) list of drug shortages. But a shortage of a commonly-prescribed antibiotic like amoxicillin can be much more serious, it means that there may be one less option should you develop a bacterial infection in your ears, nose, throat, respiratory tract, urinary tract, or skin.
Full Access: Forbes