February 16, 2021 Stewardship / Resistance Scan

FDA clears clinical trial new drug application for bacteriophage therapy

Biotechnology company Adaptive Phase Therapeutics (APT) announced last week that the Food and Drug Administration (FDA) has approved a new drug (IND) application for bacteriophage therapy for the treatment of artificial joint infections (PJIs).

Bacteriophage, or phage, is a virus that infects bacteria and can be used to combat bacterial infections.

APT officials say IND clearance can initiate Phase 1/2 trials to evaluate phage safety and surgery-saving effects in PJI patients treated with antibiotics. Phage were selected from PhageBank, a library of purified phage companies covering a broad spectrum of specific bacterial diseases, and used the phage susceptibility test developed by APT at the Mayo Clinic to accurately match the bacteria causing infection. I will.

Starting in the second quarter of 2021, APT will conduct a randomized controlled trial in collaboration with the Mayo Clinic.

“Phage therapy is a potentially groundbreaking new treatment option for PJI and other multidrug-resistant or biofilm-mediated bacterial infections, and current patient outcomes include limb loss and even life. “It is possible,” he said in a company press release at May York Clinic, which is leading a collaboration with infectious disease expert Gina Sue, MD, ATP.

According to APT, the first interim data analysis from the trial is scheduled for the first quarter of 2022.
February 10 APT Press release

Increased tolerance, gene exchange found in Campylobacter from meat

In last week’s study PLOS One, Researchers at North Carolina State University (NC) have identified an increased distribution of antimicrobial resistance (AMR) genes and virulence factors. Campylobacter Samples isolated from animals and food.

In this study, researchers at North Carolina State Veterinary School rated 541. Campylobacter Isolates collected from live chickens, turkeys, pigs, cows, poultry carcasses, and retail meat in North Carolina from January 2018 to December 2019. Campylobacter coli Most common on farms and production facilities, most were isolates from live turkey (100%), pigs (94%), chicken (54%) and carcasses of chickens (60%). Campylobacter jejuni It was a prominent species of retail chicken (69%).

90.4% by whole genome sequencing of isolates C stiffness And C Jejuni The isolate (489/541) contained at least one AMR gene, and 43.1% (233/541) contained resistance genes to three or more antibiotic classes. This is higher than the rate found in the 2017 National Antimicrobial Resistance Monitoring System monitoring. C stiffness The isolate was twice as likely C Jejuni Isolates carrying 3 or more resistance genes (odds ratio 1.9; 95% confidence interval 1.3 to 2.7).

AMR gene frequencies are tetracycline (64.3%), beta-lactam (63.6%), aminoglycoside (38.6%), macrolide (34.8%), quinolone (24.4%), lincosamide (13.5%), and streptothricin (5%). ) Was the highest. ..

Analysis shows that 57.6% C Jejuni (114/198) Carried the virulence factor of Guillain-Barré syndrome. Campylobacter Revealed further evidence of infection, and C stiffness And C Jejuni Interspecies genome exchange. The authors state that high levels of interspecific genomic exchange between the two species can alter pathogen viability and resistance trends and pose a significant public health threat.

2019, Campylobacter It was a major cause of food poisoning in the United States.

“This study shows that genome exchange is happening between C. Kori And C. jejuni, And increased antimicrobial resistance Campylobacter It was discovered in North Carolina’s poultry production, “said Dawn Hull, a PhD student at North Carolina State University, in a university press release.Campylobacter Tracking this exchange is important to prevent infection and provide future treatment, as is the leading cause of food poisoning worldwide. “
February 11 PLOS One Survey
February 15 North Carolina Press release