Stewardship / Resistance Scan for Jan 29, 2018

News brief

FDA approves oral vancomycin solution for C difficile diarrhea

CutisPharma today announced that the US Food and Drug Administration (FDA) has approved Firvanq, the company's vancomycin oral solution for treating Clostridium difficile–associated diarrhea (CDAD) and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains.

"Firvanq's approval is an important step forward to providing patients the only FDA-approved vancomycin oral liquid treatment option for Clostridium difficile associated diarrhea, a life-threatening condition that affects over a half-million patients in the United States annually," said Neal I. Muni, MD, MSPH, chief executive officer of CutisPharma, which is headquartered in Wilmington, Mass.

The formulation is expected to launch Apr 2, the company said in a news release, at which point it will replace CutisPharma's First-Vancomycin Unit-of-Use Compounding Kit, which has been an option for pharmacists to provide liquid oral therapy for CDAD. Firvanq is designed for ease of use and might be a cost-effective alternative to existing vancomycin therapies, the company said in the release.

"As a practicing infectious disease physician treating many patients with CDAD, having an FDA-approved vancomycin oral liquid formulation that is affordable and accessible to my patients is very beneficial,” said Stuart Johnson, MD, of Loyola University Medical Center, in the news release. "Patient access is currently limited by the fact that only a select few pharmacies perform compounding in the outpatient setting these days, given the many new regulations in place."
Jan 29 CutisPharma news release

Researchers stress importance of including risk factors in UTI prescribing

A single-center German study highlighting risk factors for drug resistance in upper urinary tract infections (UTIs) found that managing patients according to treatment guidelines would have led to incorrect antibiotic prescribing in almost 30% of patients.

Writing in BMC Infectious Diseases, researchers from Heidelberg University in Mannheim identified seven factors associated with antibiotic-resistance UTI infections among 137 patients, including nursing home residence, male gender, recent hospitalization, renal transplantation, and recent antibiotic use. They found that, in patients with two or more risk factors, susceptibility to ciprofloxacin dropped from 90% to 52%, compared with a 98%-to-54% drop for cefuroxime and a 98%-to-61% drop for cefpodoxime.

The investigators found that, of 124 patients with available information, only 80 (64.5%) received an empiric therapy that showed susceptibility to its causing pathogen in urine culture testing. Also, empiric therapy based on current guidelines for upper UTI would have an overall susceptibility of 71.5%. The researchers, however, were able to increase that rate to 86.1% by using an algorithm based on the risk factors they identified.

Using this algorithm, the team determined that, in patients who have no risk factors, cephalosporins seem to be the best choice for empiric therapy, but in patients with risk factors piperacillin with tazobactam is an equal or better choice than fluoroquinolones, cephalosporins, or gentamicin.

The authors concluded, "This study highlights the importance of monitoring local resistance rates and its risk factors in order to improve empiric therapy in a local environment."
Jan 26 BMC Infect Dis study

Study confirms link between high-zinc feed and resistant E coli in swine

German researchers reported in PLoS One that adding high levels of dietary zinc to feed appears to promote the persistence of multidrug-resistant (MDR) Escherichia coli in the gut of pigs.

In some countries high levels of zinc oxide are used as a feed additive to improve gut health and promote growth. And in 2015 a research team from Freie University Berlin showed an increase in MDR E coli tied to zinc feeding in piglets. But that study focused on the clonal diversity of E coli, observing the effect on MDR strains by chance.

In the new study, the researchers separated piglets into a high-zinc group and a "background zinc feeding group" that served as controls. They found that the incidence of MDR E coli increased by 28.9% to 30.2% in the high-zinc group, compared with 5.8% to 14.0% in the control group, even though the total amount of E coli detected in the pigs' guts declined over the study period. The scientists, in fact, determined that the increase in MDR E coli was independent of E coli concentrations and appeared to be linked with persistence of populations of the MDR pathogens.

"In conclusion," they write, "these findings corroborate our previous report linking high dietary zinc feeding of piglets with the occurrence of antimicrobial resistant E. coli and therefore question the feeding of high dietary zinc oxide as alternative to antimicrobial growth promoters."
Jan 26 PLoS One study

News Scan for Jan 29, 2018

News brief

Five new cases of MERS reported in Saudi Arabia

The Saudi Arabian Ministry of Health (MOH) reported five new cases of MERS-CoV in updated reports released over the weekend.

The five cases come from different cities across the country. On Jan 24, a 39-year-old Saudi woman from Riyadh was diagnosed as having MERS-CoV (Middle East respiratory syndrome coronavirus). The woman's source of infection is listed as "primary," meaning it's unlikely she contracted the disease from another person. She is in stable condition.

On Jan 25, a 47-year-old expatriate man from Al Hofuf was reported to be in critical condition with MERS-CoV. He had direct contact with camels, a known risk factor for contracting the virus. Also, a 45-year-old Saudi woman from Hail is in stable condition. She is described as contracting the virus from a household contact.

A 40-year-old male expatriate from Tabuk was diagnosed with MERS-CoV on Jan 26. He is in stable condition and his source of infection is listed as "primary." Finally, on Jan 27, a 50-year-old expatriate from Al Qunfudhah is in stable condition after contracting the virus. He had direct contact with camels.

The latest reports lift Saudi Arabia's total since the virus was first detected in humans in 2012 to 1,783, which includes 726 deaths. Eleven people are currently being treated for their infections.
Jan 24 MOH report
Jan 25 MOH report
Jan 26 MOH report
Jan 27 MOH report

North Korea requests support for 2009 H1N1 outbreak

An outbreak of 2009 H1N1 seasonal flu underway in North Korea since early December has led to 126,574 suspected cases, the country's health ministry informed the World Health Organization (WHO) on Jan 19, according to a Jan 26 bulletin from the International Federation of Red Cross and Red Crescent Societies (IFRC).

Of the suspected cases, 81,640 have been confirmed as 2009 H1N1. Four deaths have been reported, three of them in children. Nearly half of the illnesses have been in children age 17 and younger, and the outbreak is affecting the whole country, with 28.7% of the illnesses from the capital city of Pyongyang.

The government is seeking support for flu vaccination to target those high-risk groups and has asked for 30,000 oseltamivir (Tamiflu) to be tabled for healthcare workers. The WHO has so far sent 5,000 tablets for frontline health workers and vulnerable groups.

The North Korean Red Cross is meeting daily with the health ministry to coordinate activities, and the WHO and other nongovernmental agencies were briefed on Jan 24 on the developing situation. The country's Red Cross said it may heed help getting the health ministry more supplies, such as rapid test kits, and assistance with social mobilization and surveillance activities.

The report on flu activity in North Korea is notable, because little is known about the disease activity there. The WHO said in its recent global flu update that flu activity in South Korea is on the rise, mainly involving H3N2 and influenza B. And in China—North Korea's neighbor to the north—high flu activity in underway, mainly led by influenza B, but with H3N2 circulating, as well.
Jan 26 IFRC information bulletin

H5N8 strikes Iraqi poultry farms, H5N6 hits two South Korean layer farms

In the latest highly pathogenic avian influenza outbreak developments, Iraq reported two more H5N8 events at poultry farms and South Korea reported another pair of H5N6 outbreaks, according to the latest notifications from the World Organization for Animal Health (OIE).

Iraq's two H5N8 outbreaks both involved commercial farms near the capital city of Baghdad, located in the central part of the country. Start dates were Jan 15 and Jan 21, and between the two locations, the virus killed 10,000 of 31,000 susceptible birds. Authorities culled the remaining ones to control the spread of the virus.

The country reported its first H5N8 outbreak of the year earlier this month, and since then, the virus has also hit poultry in Diyala and Babil provinces. A few other Middle East countries have also reported recent H5N8 outbreaks.

Elsewhere, South Korea, which has been battling H5N6 since the middle of November, reported two more outbreaks, both involving commercial layer farms in Gyeonggi province in the country's northwest. The events began on Jan 26 and Jan 27, killing 820 of 290,700 susceptible birds. The remaining ones were destroyed as part of the outbreak response. The H5N6 implicated in South Korea's outbreaks is a reassortant between H5N8 and endemic Eurasian avian flu viruses.
Jan 29 OIE report on H5N8 in Iraq
Jan 28 OIE report on H5N6 in South Korea

Takeda granted FDA fast-track designation for Zika vaccine candidate

Japan-based Takeda announced today that the US Food and Drug Administration (FDA) has granted fast-track designation to its Zika vaccine candidate (TAK-426), an inactivated, alum-adjuvanted whole virus vaccine that is in phase 1 trials.

In a news release, Takeda said the FDA fast-track designation helps speed the review of drugs and vaccine for serious conditions and that target unmet medical needs. It added that the status paves the way for more frequent interactions with the FDA, rolling reviews of the biologic license application, and eligibility for priority review if certain conditions are met.

In 2016, the company received a contract to develop the vaccine from the US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA). In late November, Takeda announced the launch of the phase 1 trial to assess safety, immunogenicity, and different dose levels. The trial is taking place in the United States and its territories in 240 men and women ages 18 to 49 years old.

In its statement today, the company said if initial data from the trial are promising it will advance the vaccine into a phase 2 trial as soon as possible. Currently, there are no vaccine or drugs approved to battle Zika virus, which has been linked to severe birth defects, including microcephaly.
Jan 29 Takeda news release
Nov 28, 2017, CIDRAP News story "Takeda launches Zika vaccine trial; Chembio lands contract for rapid test"

Flushing toilets in hospitals capable of spraying pathogens

The spray from a flushing toilet in a healthcare setting contains particles that may contain aerosolized pathogens. That's the takeaway from the first study designed to measure bioaerosol particles near flushing toilets in hospitals.

The study, published in Antimicrobial Resistance & Infection Control, measured particle concentrations before a toilet was used and after fecal flushing, and found there was significantly more particles sized 3 microns and less in the air for 30 minutes or longer after the toilet had been used for solid waste. The study was conducted at a large 811-bed North American hospital and conducted by researchers from the University of Iowa.

"The increase of particle concentrations immediately following a flushing event provides evidence that flushing (both with and without waste) increases the airborne concentration of particles in hospital bathrooms," the authors said.

The authors suggest their data may be a springboard for future work looking at the relationship between bioaerosols and hospital-acquired infections (HAIs). Each year in America, 1.7 million people contract an HAI from a hospital-based patient care setting. Bioaerosols generated from flushing toilets may contribute to the environmental contamination and inhalation exposures experienced by patients and providers in a healthcare setting.
Jan 26 Antimicrob Resist Infect Control study

New botulinum toxin found in Enterococcus from cow feces

Researchers analyzing cow feces samples collected at a South Carolina farm discovered a strain of Enterococcus carrying a newtoxin similar to the one that causes botulism. The toxin, called BoNT/En, is the ninth botulinum toxin to be described.

The study was published today in the journal Cell Host and Microbe.

BoNT/En was found in only one cow, and the animal did not appear sick, the authors said. They made the discovery while investigating antibiotic-resistant enterococci. The bacteria are hardy microbes that line the gut of most living animals (including humans) and are susceptible to antibiotic resistance.

"BoNT-like gene clusters have not previously been identified in any bacterial species outside of Clostridium and no toxins of E. faecium have been reported before now," the authors said. "It is disconcerting to find a member of potent neurotoxins in this widely distributed gut microbe, which is a leading cause of hospital-acquired infections."
Jan 29 Cell Host Microbe study