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 pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas 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 Escherichia 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