News Scan for Dec 05, 2019

News brief

Multistate E coli romaine lettuce outbreak tops 100 cases

Yesterday the Centers for Disease Control and Prevention (CDC) said 35 more people have been sickened in an Escherichia coli outbreak tied to romaine lettuce grown near Salinas, California.

The outbreak total now stands at 102 illnesses in 23 states, with 4 states reporting their first cases.

"CDC advises that consumers not eat and retailers not sell any romaine lettuce grown in the Salinas, California, growing region. This includes all use-by dates and brands of romaine lettuce from this region," the agency said. No common grower, supplier, distributor, or brand of romaine lettuce has been identified, it added.

No deaths have been recorded in this outbreak, but 58 people have been hospitalized, with 10 developing hemolytic uremic syndrome, a type of kidney failure. Illness-onset dates range from Sep 24 through Nov 18.

Wisconsin has been hardest hit during this outbreak, with 31 cases. Ohio has reported 12, Pennsylvania has 8, and New Jersey has seen 7 illnesses.
Dec 4 CDC update

Healthcare-related infections among October Saudi MERS cases

Of the 15 cases of MERS-CoV reported to the World Health Organization (WHO) in October, 4 involved healthcare-related clusters, the agency said today in an update.

Riyadh reported the most October MERS-CoV (Middle East respiratory syndrome coronavirus) infections, at 6, followed by Aseer (5), Al Qassim (3), and Taif (1).

The first cluster involved a 39-year-old male patient in Aseer province and a 26-year-old female healthcare worker (HCW). The other cluster involved a 32-year-old male patient and a 49-year-old female HCW in Riyadh.

Five of the 15 patients, all with diabetes, died. Six other patients had diabetes, and, of the 11 diabetic patients, 8 had other underlying medical conditions, as well. One patient without diabetes—the 49-year-old female HCW—had high blood pressure. Only 3 patients had no preexisting condition.

Three of the patients reported recent camel contact, which is a known MERS risk factor. All three drank camel milk. All 15 patients were adults who required hospitalization, and only 3 were women. Patient ages ranged from 26 to 94.

The WHO said that, since the disease was first reported in 2012, it has received reports of 2,484 lab-confirmed cases, including 857 deaths. Saudi Arabia has been by far the hardest-hit nation.
Dec 5 WHO update

Georgia girl hospitalized with Eastern equine encephalitis

An 8-year-old girl from Savannah, Georgia, was hospitalized for 1 month after contracting Eastern equine encephalitis (EEE) a rare mosquito-borne disease, according to a media report flagged on ProMED Mail, the online reporting system of the International Society for Infectious Diseases.

The girl—who suffered extensive brain damage—is still recovering from the illness, which took doctors several weeks to correctly diagnose. She was admitted to the hospital on Nov 4, and was not diagnosed with EEE until Dec 2. ProMEd cites a report from WTOC, a Savannah TV station.

As of Dec 3, the CDC said officials have confirmed 37 EEE case this year, including 15 deaths (40.5%), reported in nine states other than Georgia: Alabama (1), Connecticut (4), Indiana (1), Massachusetts (12), Michigan (10), North Carolina (1), New Jersey (4), Rhode Island (3), and Tennessee (1).

The CDC tracks an average of 7 EEE cases annually, with 30% resulting in death. Typically, cases come from the Gulf states. Many survivors suffer long-term neurologic problems.
Dec 4 ProMed Mail post
Dec 3 CDC EEE report

FDA, NIH create app for novel drug use for difficult-to-treat infections

Today the US Food and Drug Administration (FDA) announced the global launch of CURE ID, a web-based repository to allow HCWs to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs.

The app enables the crowdsourcing of medical data from HCWs to guide interventions and facilitate the development of new drugs for neglected diseases. It can be accessed via smart phone, tablet, or other mobile device, or via a website. CURE ID is a collaboration between the FDA and the National Center for Advancing Translational Sciences, which is part of the National Institutes of Health.

The repository captures clinical outcomes when professionals prescribe drugs for new indications, in new populations, in new doses, or in new combinations. HCWs are allowed to prescribe a legally marketed human drug or device for an unapproved or uncleared use when they deem it appropriate for an individual patient.

"The CURE ID application focuses on drugs for infectious diseases lacking adequate treatments, including neglected tropical diseases, emerging infectious threats and infections caused by antimicrobial-resistant organisms," said Amy Abernethy, MD, PhD, an FDA principal deputy commissioner, in an FDA news release. "When health care professionals directly input their clinical cases into the app, CURE ID allows these real-world experiences to be organized and analyzed much faster, making it easier to spot promising new uses for existing drugs."
Dec 5 FDA news release
FDA CURE ID landing page

Osivax and NIAID ink plan to test universal flu vaccine

Osivax, a pharmaceutical firm based in Lyon, France, announced today that it has signed an agreement with the National Institute of Allergy and Infectious Diseases (NIAID) to continue development of the company's universal flu vaccine candidate.

The vaccine, known as OVX836, targets nucleoprotein, a highly conserved antigen in influenza viruses. Osivax said in a press release that it is funding a phase 1 trial of the vaccine.

As part of the agreement, Osivax will use NIAID's preclinical services to do a more detailed immunologic assessment of OVX836, including its effect on cellular immune, CD4, CD8, and T-cell response. The company said the studies will enable it to get a deeper and more complete assessment of the vaccine's impact.
Dec 5 Osivax press release

Stewardship / Resistance Scan for Dec 05, 2019

News brief

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