Stewardship / Resistance Scan for Jun 25, 2019

Highly resistant gonorrhea in Taiwan
New pneumonia antibiotic
UK AMR funding

High-level azithromycin-resistant gonorrhea increases in Taiwan

A study yesterday in Antimicrobial Agents and Chemotherapy details the emergence of gonorrhea strains with high-level resistance to azithromycin in Taiwan.

In an evaluation of 598 Neisseria gonorrhoeae isolates obtained from patients in Taiwan from 2001 to 2018, researchers found that 8.7% (52 of 598 isolates) were resistant to azithromycin and 1.7% (10/598) exhibited high-level resistance. All of the isolates with high-level azithromycin resistance had non-mosaic penA alleles and the same molecular resistance determinants, including four mutated 23S rRNA copies with A2059G mutation, -35A deletion in the promoter region of the mtrR gene, and G45D mutation in the mtrR coding region.

An analysis of the genetic relatedness of the 52 isolates found 24 different multilocus sequence typing (MLST) types, with ST1901, ST1583, ST7371, and ST11196 being the most prevalent among the azithromycin-resistant isolates. Among the 10 isolates with high-level azithromycin resistance, nine were identified as MLST12039 and one belonged to MLST10899. The results of genotyping and pulsed-field gel electrophoresis suggest the clonal spread of high-level azithromycin-resistant isolates in Taiwan and the circulation of a certain strain through sexual networks, instead of de novo development.

Among the 10 patients infected with high-level azithromycin-resistant N gonorrhoeae, 9 were diagnosed in 2017-18, and 1 was infected in 2013. Geographical spread was throughout Taiwan, and no sexual contact was reported between any of the patients.

The researchers say these findings suggest that Taiwan should consider following the guidance of the British Association for Sexual Health and HIV and recommend a single dose of ceftriaxone intramuscularly as the first choice for treatment of N gonorrhoeae infections, rather than the widely recommended dual therapy of ceftriaxone and azithromycin.
Jun 24 Antimicrob Agents Chemother abstract


European regulators to review new pneumonia antibiotic

Drug maker Nabriva Therapeutics of Dublin announced yesterday that the European Medicines Agency (EMA) has determined that the marketing authorization application (MAA) for the oral and intravenous (IV) formulations of lefamulin is valid.

The validation means that the EMA Committee for Medicinal Products for Human Use will now begin the formal review process for lefamulin, a semi-synthetic pleuromutilin antibiotic for treating community-acquired pneumonia (CAP) in adults. If approved, the drug would receive marketing authorization in all 28 European Union member states, as well as in Iceland, Norway, and Lichtenstein. An opinion is expected within the next 12 to 15 months.

"We are grateful for the EMA's quick validation of our MAA submission and look forward to working with the EMA during the MAA review process.  We are committed to providing European patients with CAP the potential option of short course treatment with IV or oral lefamulin," Nabriva Chief Medical Officer Jennifer Schranz, MD, said in a company press release.

Two phase 3 clinical trials demonstrated that lefamulin was non-inferior to moxifloxacin for the treatment of adults with CAP, and was well-tolerated, the company said.

Nabriva also has New Drug Applications (NDAs) for oral and IV lefamulin currently under review by the US Food and Drug Administration (FDA). The FDA is expected to complete its fast-tracked review by Aug 19. 
Jun 24 Nabriva Therapeutics press release
Feb 21 CIDRAP News scan on lefamulin NDA approval


UK announces new AMR funding

The British government is awarding £32 million ($40.6 million US) to 10 UK research centers working to combat antimicrobial resistance (AMR), according to a UK Department of Health and Social Care (DHSC) news release.

Among the institutions receiving the funding is Imperial College London, which will receive £4 million ($5.1 million) for the Centre for Antimicrobial Optimisation. The center aims to develop new technologies and innovative approaches to improve the use of antibiotics. Public Health England will receive £5 million ($6.4 million) to develop a model hospital ward to study how hospitals can be designed to improve infection control and reduce transmission of drug-resistant infections.

The funding is part of the British government's 20-year-vision and 5-year national action plan on AMR.

The government also announced that Dame Sally Davies, the UK's outgoing chief medical officer, will become a special UK envoy on AMR.

"The UK should be proud of its world-leading work on AMR," Davies said in the DHSC press release. "We have made tangible progress but it is essential we maintain momentum. I am honoured to have been asked to continue this vital work on behalf of the UK government."
Jun 23 DHSC press release
Jun 24 Imperial College London press release

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