Stewardship / Resistance Scan for Nov 05, 2019

News brief

Fecal transplant for C diff tied to fewer bloodstream infections, deaths

Fecal microbiota transplant (FMT) for Clostridioides difficile infection (CDI) was associated with a dramatic decrease in bloodstream infections (BSIs), days of hospitalization, and death rates compared to treatment with antibiotics, according to a prospective cohort study today in the Annals of Internal Medicine.

Italian investigators studied 290 adults hospitalized at a tertiary care hospital in Rome from July 2013 to May 2018 for recurrent CDI (rCDI). Of those patients, 109 were treated with FMT and 181 with antibiotics. The authors said that, on average, patients receiving FMT began therapy with worse clinical conditions than the antibiotics patients.

The researchers found that those in the FMT group had a risk for BSI 24.1 percentage points lower than the patients receiving antibiotics (4.6% vs 28.7%). Length of hospital stay was 13.3 days in patients treated with FMT compared with 29.7 for those treated with antibiotics.

In the whole cohort, 79 of 290 patients (27%) died during the 90-day follow-up period, 21 of them—all in the antibiotics group—because of BSI. Overall 90-day fatality rate was 8.3% in the FMT patients and 38.7% in the antibiotics patients. In addition, 106 FMT patients (97.2%) had sustained CDI cure, far better than the 69 (38.1%) in the antibiotics group.

The authors conclude, "Should our results be confirmed by larger, randomized studies, FMT could be considered an effective treatment option to both cure rCDI and prevent some of its complications, including BSI."
Nov 5 Ann Intern Med abstract

Peer comparison intervention leads to lower antibiotic prescribing rates

Physician education and monthly peer comparison of overall antibiotic prescribing rates led to a decrease in unnecessary antibiotic prescribing within the Veterans Affairs (VA) health system, according to a new study in Antimicrobial Agents and Chemotherapy.

The study looked at an antimicrobial stewardship intervention in seven VA primary care health clinics in Pittsburgh, and compared antibiotic prescribing rates before and after the intervention in 2016 and 2017. Primary care physicians (PCP) were asked to attend an education session and then sent a monthly email comparing their prescribing rate with peers' and a VA system target.

During the intervention period of January through June 2017, there were 73 PCPs caring for 41,191 patients, and 32,982 office visits.

According to the authors, the intervention led to a mean monthly antibiotic prescriptions decline of 76.9 to 49.5 per 1,000 office visits (35.6% reduction, P<0.001). Among reviewed cases, unnecessary antibiotic prescribing declined (58.8% [80/136] vs. 38.9% [70/180], 33.9% reduction, P=0.0006), and optimally prescribed antibiotics increased (19.9% [27/136] vs. 30% [54/180], 50.8% increase, P=0.05).

There was not, however, a significant difference in the prescribing of guideline-discordant agents (21.4% [12/56] vs 19.1% [21/110], P=0.8) or guideline-concordant agents for a guideline-discordant duration. Inappropriate antibiotic prescriptions were significantly reduced for skin and soft-tissue infections, the authors said.

"This is the first study to show that a stewardship strategy built upon feedback to PCPs about their overall use of outpatient antibiotics, without regard to appropriateness of treatment, is effective in diminishing unnecessary antibiotic usage and optimizing treatment within a healthcare system," the authors concluded.
Nov 5 Antimicrob Agents Chemother study

FDA approves new antibiotic treatment for H pylori infections

The US Food and Drug Administration (FDA) has approved RedHill Biopharma's Talicia (antibiotics amoxicillin and rifabutin combined with proton pump inhibitor omeprazole) for the treatment of Helicobacter pylori infections in adults. RedHill said they plan to launch the drug in the United States in the first quarter of 2020.

Approximately 35% of the US adult population is infected with H pylori, which translates to 2.5 million patients treated annually. Current therapies fail in approximately 25% to 40% of patients who remain H pylori positive due to growing resistance to clarithromycin and metronidazole.

Talicia is designed to address drug resistance and diminished efficacy of clarithromycin-based standard-of-care therapy. The bacteria it is classified as a Group I carcinogen, and is the strongest risk factor for the development of peptic ulcer disease, gastritis and non-cardia gastric cancer, RedHill said.

"Talicia offers patients a much-needed new treatment option for H. pylori with an excellent safety and efficacy profile that is not compromised by clarithromycin or metronidazole resistance. The clinical studies for Talicia demonstrated high efficacy in eradication of H. pylori. Studies with Talicia found zero resistance to rifabutin and showed 17% resistance to clarithromycin," said David Y. Graham, MD,, the lead investigator for Talicia's phase 3 studies in a press release.
Nov 5 RedHill Biopharma press release

News Scan for Nov 05, 2019

News brief

DRC confirms 7 more Ebola cases, lifting total to 3,282

After going 2 days with no new cases, the Democratic Republic of the Congo (DRC) today reported 7 new lab-confirmed cases and 1 additional probable infection, raising the overall outbreak total to 3,282, which includes 118 probable cases, according to the World Health Organization (WHO) online Ebola dashboard.

Health officials are still investigating 447 suspected Ebola cases.

No new deaths were reported, keeping the fatality count at 2,185.

The DRC's Ebola technical committee (CMRE) said in its daily update yesterday that a 37-year-old woman who is a vaccinated high-risk contact was intercepted at a checkpoint in Kiwandja while traveling from Oicha to Goma, the capital of North Kivu province. It added that she was handed over to the surveillance team for follow-up.
WHO online Ebola dashboard
Nov 4 CMRE update

FDA approves 4-strain version of Sanofi's high-dose flu vaccine for seniors

Sanofi yesterday announced that the US Food and Drug Administration (FDA) has approved a supplemental biologics license application for its Fluzone high-dose quadrivalent (four-strain) flu vaccine for use in those age 65 and older.

In 2009, the FDA approved the trivalent version of Sanofi's high-dose flu vaccine for seniors. The FDA based its approval on data from a phase 3 immunogenicity and safety study, which suggested the quadrivalent vaccine was noninferior to two trivalent Fluzone versions, each containing a different influenza B strain. In a secondary endpoint, each influenza B strain in the quadrivalent vaccine induced a better immune response compared to the trivalent formulation that didn't contain the corresponding B strain.

David Loew, the company's executive vice president and head of Sanofi Pasteur, said in a press release, "We are excited to build upon the success of trivalent Fluzone High-Dose with this FDA approval to expand protection for an additional B strain. We have submitted filings with additional regulatory bodies outside the U.S. and anticipate approval in the European Union next spring."

The FDA's recent approval means that all of Sanofi's flu vaccines have transitioned to quadrivalent versions. The company said its high-dose quadrivalent will be available during the 2020-2021 flu season and that it will continue to deliver and offer the trivalent formulation for the rest of the current season.
Nov 4 Sanofi press release

BARDA funds over-the-counter flu test

The Biomedical Advanced Research and Development Authority (BARDA) at the US Department of Health and Human Services is giving Lucira Health up to $11.5 million in additional funding to further develop the company's over-the-counter influenza test and develop a telemedicine workflow for the product.

The funding will execute the second phase of Lucira's contract with BARDA.

"This second tranche of funding will ensure that we complete our clinical studies and put our product in the hands of consumers," said President and CEO of Lucira, Erik Engelson in a press release. "The trust and support of BARDA motivates our team to push further and to enable influenza management in the home."

The test consists of a nasal swab that provides a text read-out of results within 20 minutes on a battery-powered device. The telemedicine component of the funding will go towards establishing how consumers will manage follow-up care after the use of the test at home.
Nov 5 Lucira press release

Lesotho reports measles outbreak in remote district

Lesotho is experiencing its first measles outbreak in almost 10 years, which is occurring in a previously unaffected area, the WHO African regional office said today in its weekly outbreaks and health emergencies report.

The country, which only reported one measles case in 2018, has targeted measles as one of the diseases for elimination, and surveillance guidelines define an outbreak as three or more cases confirmed from the same health facility. On Oct 26, Lesotho's health ministry notified the WHO of a measles outbreak in remote Oacha Nek district, based on 4 positive blood tests collected from 50 suspected case-patients who visited the same health facility with symptoms that included fever and body rash. Most of the patients are children ages 5 to 12 years old. One of the samples was positive for rubella.

Vaccine coverage for measles vaccine has been low in the affected district for the past 4 years, and coverage was 65% for 2019. However, the WHO said Lesotho's national coverage has remained high.

A mass vaccination campaign is being planned for the affected area, targeting children ages 9 months to 15 years.
Nov 5 WHO African regional office weekly report