FDA approves new 1-dose antibiotic for treating bacterial vaginosis
Symbiomix Therapeutics announced yesterday that the US Food and Drug Administration (FDA) on Sep 15 approved its antibiotic Solosec (secnidazole) for treating bacterial vaginosis (BV) in adults, the first single-dose option for the condition.
The Newark, N.J.–based company said in a news release, "The FDA approval was supported by a comprehensive set of studies, including two pivotal trials in BV and an open label safety study, which found efficacy for single-dose secnidazole 2g. All treatment-emergent adverse events were mild or moderate in intensity; no serious adverse events were reported, and no patients discontinued treatment due to adverse events."
The FDA awarded the company fast-track designation, which made Solosec eligible for priority review and at least 10 years of US market exclusivity. BV is the most common gynecologic infection in the United States, affecting 21 million girls and women aged 14 to 49 each year, Symbiomix said. The most commonly prescribed antibiotics for the condition require twice-a-day pills for 7 days.
Solosec granules are designed to be sprinkled onto applesauce, yogurt, or pudding and consumed within 30 minutes without chewing the granules.
David L. Stern, CEO of Symbiomix, said in the news release, "Solosec is the first new oral antibiotic to treat BV in more than a decade and will provide women with a new treatment option. We look forward to making this treatment available to patients in the first quarter of 2018."
Sep 18 Symbiomix news release
Whole-genome sequencing effective in tracing spread of resistant bacteria
Phylogenetic analysis based on whole-genome sequencing (WGS) was superior to conventional epidemiologic methods for reconstructing transmission pathways in an outbreak of carbapenem-resistant Klebsiella pneumoniae at a Leipzig hospital, German scientists reported yesterday.
From July 2010 to April 2013, Leipzig University Hospital experienced its largest-ever outbreak of carbapenem-resistant K pneumoniae infections. The researchers, writing in the American Journal of Infection Control, aimed to reconstruct transmission pathways after the outbreak ended.
The investigators performed WGS on 117 isolates from 89 outbreak patients, 5 matching environmental strains, and 24 K pneumoniae strains not linked to the outbreak. They confirmed a patient from Greece as the source of the outbreak. By applying strict definitions in an epidemiologic investigation, they were able to explain transmission pathways for 11 (12.4%) of the 89 patients. Using phylogenetics, in contrast, they were able to confirm 5 of these plus an additional 15 pathways—for a total of 20 (22.5%).
The authors conclude, "Effective phylogenetic identification of transmissions requires systematic microbiologic screening. Extensive screening and phylogenetic analysis based on WGS should be started as soon as possible in a bacterial outbreak situation."
Sep 18 Am J Infect Control study
Review: Tetracyclines pose lower risk of C difficile
A new meta-analysis conducted by researchers at the Mayo Clinic suggests tetracyclines offer a lower risk of Clostridium difficile infection than other antimicrobials. The findings were published yesterday in Clinical Infectious Diseases.
Researchers analyzed six studies collected from several databases. The studies included hospital patients recruited between 1993 and 2012. They found that use of tetracyclines was negatively associated with C difficile, at an odds ratio of 0.62.
The authors conclude that tetracyclines may be used as a first line treatment when prescribers are concerned about C difficile infection, a life threatening condition most commonly associated with healthcare settings. The bacteria, which flourishes after treatment and overuse of antibiotics, inflames the colon, leading to colitis.
Sep 18 Clin Infect Dis study