ASP Scan (Weekly) for Feb 02, 2018

Gram-negative pneumonia antibiotic
Antibiotic-resistant E coli
Colistin use in Indian poultry
AMR threat in Southeast Asia
Contaminated ice machines
MDR-TB cases in Georgia
Resistant Campylobacter in pups
New antimicrobials
Oral C diff drug approved
Tailored UTI prescribing
Zinc in pig feed and MDR E coli

Our weekly wrap-up of antimicrobial stewardship & antimicrobial resistance scans

FDA approves gram-negative antibiotic for pneumonia

Allergan, a pharmaceutical company based in Dublin, Ireland, yesterday announced that the US Food and Drug Administration (FDA) has approved an expanded indication for its antibiotic combination drug Avycaz (ceftazidime and avibactam) to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by gram-negative organisms.

In a statement, the company said the drug is the first gram-negative antibiotic drug approved in the past 15 years to treat HABP and VABP, which are some of the most challenging gram-negative infections in hospital settings. The indication applies to the following seven gram-negative organisms in adults: Klebsiella pneumoniaeEnterobacter cloacaeEscherichia coliSerratia marcescensProteus mirabilisPseudomonas aeruginosa, and Haemophilus influenzae.

Certain gram-negative bacteria have become increasingly resistant to available antibiotics, leading to increased illness and death and driving healthcare costs higher, the company said.

David Nicholson, PhD, Allergan's chief research and development officer, said, "Gram-negative pathogens are some of the most pressing antibiotic resistance threats and cause more than 40,000 resistant infections in the U.S. annually. Today's action by the FDA is further evidence of Allergan's commitment to improving outcomes and meeting critical needs in patients with life-threatening infectious diseases."

Avycaz was first approved in February 2015 for treating adults with complicated intra-abdominal infections, when combined with metronidazole. In 2017 the company received an expanded indication for treating certain types of complicated urinary-tract infections. The new indication for HABP and VABP was based on a phase 3 trial that compared Avycaz to meropenem in 870 hospitalized patients who had HABP or VABP.
Feb 1 Allergan press release


UK study finds high antibiotic resistance in E coli of preschoolers with UTI

About 43% of E coli isolated from the urine of preschoolers with urinary tract infections (UTIs) in Britain are antibiotic resistant, and recent exposure to antibiotics appears to increase the risk, according to a study this week in the Journal of Antimicrobial Chemotherapy.

Researchers from a handful of UK universities analyzed data on 824 children who were under 5 years old and had consulted a primary care physician for an acute illness. The data were part of the Diagnosis of Urinary Tract Infection in Young Children (DUTY) study.

The scientists found that 43.0% of isolates were resistant to at least one tested antibiotic, with resistance levels to amoxicillin highest: 49.4% in pathogens and 37.3% in contaminants. Trimethoprim (27.9% and 16.5%, respectively) and co-amoxiclav (16.5% and 21.5%) were next. Resistance to three or more antibiotic groups was present in 17.1% of pathogens and 30.1% of contaminants.

Exposure to antibiotics in the previous 3 months was associated with resistance in both pathogens (adjusted odds ratio [aOR], 1.10) and contaminants (aOR, 1.69).
Jan 29 J Antimicrob Chemother study


Investigative report finds widespread colistin use in Indian poultry

Originally published by CIDRAP News Feb 1

A new story by the UK-based Bureau of Investigative Journalism alleges the last-resort antibiotic colistin is being widely used on Indian poultry farms, despite worldwide concerns that using the drug in food-producing animals could render it ineffective.

According to the story, India is importing at least 150 tons of colistin each year, and at least five animal pharmaceutical companies in India are openly advertising products containing colistin as growth promoters.

Colistin resistance emerged as a global concern in 2015, when scientists discovered the colistin resistance gene MCR-1 in E coli bacteria isolated from pigs, pork products, and humans in China. Since then the gene, which is located on mobile pieces of DNA called plasmids and can be transferred within and between different bacterial species, has spread around the globe in animals and humans. Public health officials fear that when already multidrug-resistant bacteria acquire MCR-1, untreatable infections could result.

"Colistin is the last line of defense," Timothy Walsh, PhD, an antibiotic resistance expert at Cardiff University who was a member of the team that discovered MCR-1, told the Bureau of Investigative Journalism. "It is the only drug we have left to treat critically ill patients with a carbapenem-resistant infection. Giving to chickens as feed is crazy."

The emergence of MCR-1 has been linked to widespread use of colistin on Chinese farms, and in 2016 China announced that it would no longer allow use of the drug in food-producing animals. While many countries have banned use of colistin as a growth promoter, it is still used for disease prevention. In November 2017, the World Health Organization recommended restrictions on the use of medically important antibiotics like colistin in food-producing animals, including a ban on their use for growth promotion.
Jan 30 Bureau of Investigative Journalism story


FAO official calls Southeast Asia a 'hot spot' for AMR

Originally published by CIDRAP News Feb 1

Widespread misuse of antibiotics in food production in Southeast Asia could magnify the threat of antimicrobial resistance (AMR) in the region, an official with the Food and Agriculture Organization (FAO) told Reuters yesterday.

FAO Chief Veterinary Officer Juan Lubroth told the news service that intense food and agriculture production, combined with high population growth, in Southeast Asia's megacities could create increased risks for drug-resistant bacterial infections in humans.

"Here in Southeast Asia…we would consider it a hotspot because of the population growth, urbanization dynamics, the production of food," Lubroth said.

The comments were made on the sidelines of a meeting in Bangkok of the Interagency Coordination Group on Antimicrobial Resistance, a body formed to guide countries in the creation of national AMR action plans and ensure sustained global action against the AMR threat.

Lubroth said the FAO advocates educating farmers about the dangers of using medically important antibiotics to promote growth in food animals, and wants stronger enforcement of rules governing food production.
Jan 31 Reuters story


Contaminated ice machines could spread microbes, researchers say

Originally published by CIDRAP News Feb 1

Ice machines in healthcare facilities are often contaminated with gram-negative bacilli and Candida species and are a potential source of dispersal for these organisms, researchers reported yesterday in Infection Control and Hospital Epidemiology.

In a two-part study conducted at 5 hospitals and 2 nursing homes in northeast Ohio, researchers took swab samples from 64 ice machines. In visual assessments prior to culture collection, many of these machines had stagnant water in the drain pan, had drain pans with visible grime and a layer of slime, and showed visible water dispersal onto surrounding countertops or the floor.

Gram-negative bacilli and/or Candida spp were recovered from 100% of drain pans, 52% of ice chutes, and 72% of drain-pan grilles. Of the 91 colonies of bacilli further analyzed, 55 (60.4%) were Enterobacteriaceae, and 7 isolates were resistant to carbapenems, including single isolates of K pneumoniae, Acinetobacter baumannii, and E cloacae.

In the second part of the study, the researchers investigated potential mechanisms of microbial dispersal by observing how the machines were used and conducting simulations in five of the machines using a fluorescent lotion to trace the path of microbes. This revealed that ice frequently fell through the drain pan grille and melted in the drain pan, resulting in stagnant, contaminated water; when more ice cubes fell through the grille into the contaminated water, the splattering dispersed microbes to the hands of users, cups, and the drain pan grille. They also found that contamination of the ice chute could result in contamination of ice cubes exiting the chute.

"Effective strategies to prevent the dispersal of microorganisms contaminating ice machines need to be developed," the authors conclude. "Regularly scheduled cleaning of ice machines has been recommended and may be beneficial in reducing the burden of microbes such that dispersal is reduced."
Jan 31 Infect Control Hosp Epidemiol abstract


Georgia health officials investigate 3 MDR-TB cases

Originally published by CIDRAP News Jan 31

The Georgia Department of Public Health (GDPH) tuberculosis program is assisting with the investigation of two confirmed multidrug-resistant tuberculosis (MDR-TB) cases in the northeastern part of the state, according to Nancy Nydam, a communications official with the GDPH.

The two patients are receiving treatment, and a third possible case is under evaluation. Contacts, including children, are undergoing screening with blood tests and x-rays.

Out of an abundance of caution, the GDPH has alerted hospital emergency departments and health providers who may see patients from Hart, Franklin, or Stephens counties, or areas nearby. "This is a proactive, precautionary step to screen individuals with signs and symptoms of TB, especially due to the number of influenza-like illnesses that so many people are experiencing," Nydam told CIDRAP News. Symptoms of can include prolonged cough, coughing up blood or blood-stained mucus, fever, night sweats, weight loss, or malaise.
CDC MDR-TB fact sheet


CDC closes investigation into puppy-related Campylobacter outbreak

Originally published by CIDRAP News Jan 31

The Centers for Disease Control and Prevention (CDC) yesterday announced an end to its investigation into a multistate outbreak of multidrug-resistant Campylobacter linked to puppies from Petland pet stores.

Since the last update in mid-December, the agency confirmed 16 more cases, bringing the totals to 113 cases in 17 states. Although the investigation is over, the CDC said there could still be more cases reported because people could be unaware of the risks after coming into contact with infected puppies and dogs.

No deaths were reported during this outbreak, but there were 22 hospitalizations. Illnesses started from Jan 12, 2017 to Jan 7, 2018. Bacteria isolated from 5 ill people and 7 puppies showed that the Campylobacter was resistant to common, first-line antibiotics, including  azithromycin, ciprofloxacin, clindamycin, erythromycin, nalidixic acid, telithromycin, and tetracycline.

Almost all patients (99%) reported contact with a puppy in the week prior to illness, 87% reported contact with a puppy from a Petland store, and 25 were employees of Petland stores. Whole-genome sequencing during the outbreak showed that Campylobacter isolates were closely related.

"Pet owners should be aware that any puppy or dog, regardless of where it is purchased or adopted, may carry germs like Campylobacter that can make people sick," the CDC said. "Always wash your hands thoroughly with soap and water right after touching puppies and dogs or after picking up their poop." 
Jan 30 CDC notice


FDA offers guidance on new antimicrobials under GAIN Act

Originally published by CIDRAP News Jan 30

The FDA yesterday published guidance for industry on the implementation of the Generating Antibiotic Incentives Now (GAIN) Act, detailing policies and procedures related to the designation of a qualified antimicrobial under the 2012 law.

GAIN offers incentives for the development of antibacterial and antifungal drugs to treat serious infections, including those that are life-threatening. The primary incentive to pharmaceutical companies is a 5-year exclusivity extension for drug products that have been designated and approved as a qualified infectious disease product (QIDP). A QIDP can also receive FDA fast-track status.

Yesterday's guidance states, "For a drug product to be designated a QIDP, the sponsor is required to demonstrate that the drug is an 'antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections.' A sponsor requesting a QIDP designation may also include documentation that the product is intended to treat an 'antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens' or a qualifying pathogen as part of the designation request; however, such documentation is not required."

The FDA said it will respond to QIDP designation requests within 60 days of submission.
Jan 29 FDA guidance


FDA approves oral vancomycin solution for C difficile diarrhea

Originally published by CIDRAP News Jan 29

CutisPharma today announced that the 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

Originally published by CIDRAP News Jan 29

A single-center German study highlighting risk factors for drug resistance in upper 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-resistant 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

Originally published by CIDRAP News Jan 29

German researchers reported in PLoS One that adding high levels of dietary zinc to feed appears to promote the persistence of multidrug-resistant (MDR) E 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 Ecoli and therefore question the feeding of high dietary zinc oxide as alternative to antimicrobial growth promoters."
Jan 26 PLoS One study

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