FDA approves test that speeds MRSA screening
The US Food and Drug Administration (FDA) today approved a new test to diagnose methicillin-resistant Staphylococcus aureus (MRSA), which will allow health workers to screen patients for MRSA colonization more quickly—in as little as 5 hours compared with 24 to 48 hours for traditional culture-based tests.
The test, known as cobas vivoDx MRSA, is marketed by Roche Molecular Systems, Inc, of Pleasanton, California. According to an FDA news release, the test uses a new bacteriophage technology based on luminescence that can detect MRSA in nasal swabs. Data presented during the review process showed that the test correctly identified MRSA in about 90% of samples when MRSA was present and detected no MRSA in 98.6% of samples that did not contain the bacteria.
The FDA evaluated the test through its de novo premarket review pathway for new types of low-to-moderate risk devices. The agency said it is developing new types of controls for this type of test, which covers labeling and design verification and validation to address certain risks, such as false-positives. It said meeting those and general controls provides reasonable assurance and safety for these types of tests and that the actions create a new regulatory classification that subsequent devices will be measured against.
Tim Stenzel, PhD, MD, who directs the FDA's Office of In Vitro Diagnostics and Radiological Health in its Center for Devices and Radiological Health, said in the release, "Today's authorization adds a new tool in the fight to prevent and control MRSA in high-risk settings. The FDA remains committed to supporting efforts to address antimicrobial resistance in order to better protect patients against this ongoing public health challenge."
Dec 5 FDA press release
CARB-X announces funding for new microbiome therapy
The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) today announced funding of up to $5.8 million for the development of an oral therapy designed to restore healthy gut bacteria and help fight infection and colonization with multidrug-resistant organisms (MDROs).
The award to Vedanta Biosciences, of Cambridge, Massachussets, will support development of VE707, the company's preclinical human microbiome program. VE707 consists of commensal, non-pathogenic bacterial strains and is designed to decolonize patients who have gut-dwelling MDROs and are at high risk of developing infections. The therapy is being specifically developed to eliminate intestinal carriage of carbapenem-resistant Enterobacteriaceae, extended-spectrum beta-lactamase producers, and vancomycin-resistant Enterococcus.
"If we could get rid of intestinal carriage of these MDROs in high risk patients, we could not only prevent infections, but also curb the transmission of these organisms and enable physicians to avoid using antibiotics that select for ever-more resistant bacterial strains," Vedanta CEO Bernat Olle, PhD, said in a CARB-X press release.
Vedanta could receive an additional $3.5 million in funding for VE707 from CARB-X if certain project milestones are met.
Dec 5 CARB-X press release
Phase 3 trial demonstrates safety, efficacy of delafloxacin for pneumonia
The results of a phase 3 clinical trial comparing the efficacy and safety of delafloxacin to moxifloxacin for treating community-acquired bacterial pneumonia (CABP) appeared today in Open Forum Infectious Diseases.
In the randomized, multicenter trial, 859 CABP patients from study centers in 18 countries were assigned in a 1:1 ratio to receive either intravenous (IV)/oral delafloxacin or IV/oral moxifloxacin, with a primary end point of early clinical response—defined as 96 hours after the first dose of the study drug—in the intention-to-treat (ITT) population. Clinical response at test of cure (TOC) and microbiologic response at TOC were also assessed. The noninferiority margin was 12.5%.
The results showed that, in the ITT population, early clinical response rates were 88.9% in the delafloxacin group and 89.0% in the moxifloxacin, demonstrating noninferiority. Clinical success rates at microbiologic eradication at TOC were also similar between the two groups (90.5% for delafloxacin vs 89.7% for moxifloxacin), and data further showed that delafloxacin successfully eradicated key respiratory pathogens at rates comparable to moxifloxacin.
Treatment-emergent adverse events at least possibly related to the study drug occurred in 65 patients in the delafloxacin group (15.2%), compared with 54 in the moxifloxacin group (12.6%).
"With properties unique from other fluoroquinolones, delafloxacin monotherapy is effective and well-tolerated in the treatment of adults with CABP, providing coverage for gram-positive (including MRSA), gram-negative, and atypical pathogens commonly associated with CABP," trial investigators write.
The FDA's Oct 24 approval of delafloxacin for the treatment of patients with CABP was based on the trial results.
Dec 5 Open Forum Infect Dis abstract