first_imgMeta-analysis finds little use for procalcitonin in guiding CAP treatmentA meta-analysis of 12 studies indicates that serum procalcitonin levels are unlikely to help clinicians determine whether community-acquired pneumonia (CAP) in adults requires antibiotics, researchers from Baylor College of Medicine reported yesterday in Clinical Infectious Diseases.The US Food and Drug Administration (FDA) approved the use of procalcitonin—a peptide with serum levels that are believed to increase during bacterial infections—to help clinicians determine whether antibiotics are needed, and when they should be stopped, in patients with lower respiratory tract infections, including CAP. But the researchers note that many of the studies supporting the procalcitonin-guided protocol have been in pediatric patients in whom etiologies have been established, or adults with a variety of respiratory disorders. They wanted to evaluate the performance of procalcitonin in adult CAP patients in whom the etiology was established.In their review of the 12 studies, which included 2,408 adult patients hospitalized with CAP, the researchers found that the sensitivity and specificity of serum procalcitonin (at a cutoff of 0.5 micrograms per liter) were 0.55 (95% confidence interval [CI], 0.37 to 0.71) and 0.76 (95% CI, 0.62 to 0.86), respectively. From these results, they determined that the sensitivity and specificity of procalcitonin are both too low and too variable to be used in distinguishing bacterial from viral pneumonia and determining whether antibiotics are needed.Jun 25 Clin Infect Dis abstract Greek data reveal high prescribing rate for kids’ urinary tract infectionsGreek researchers have identified high prescribing rates and prolonged intravenous antibiotic treatments in children treated for urinary tract infections (UTIs) at a Greek hospital, according to a study yesterday in the Journal of Global Antimicrobial Resistance.Among 230 neonates, infants, and older children admitted to the hospital with a UTI over a 5-year period, 459 antibiotic prescriptions were identified, with amikacin (31.2%), amoxicillin-clavulanic acid (17.4%), and ampicillin (13.5%) the most commonly prescribed agents. Children received prolonged IV treatment for febrile and afebrile UTIs for a mean of 5.4 days and 4.7 days, respectively. Analysis of isolates found that the main causative organism was Escherichia coli (79.2%), and high resistance rates were reported for ampicillin (42%), trimethoprim-sulfamethoxazole (26.5%), and amoxicillin-clavulanic acid (12.2%). Lower resistance rates were identified for 3rd generation cephalosporins (1.7%), nitrofurantoin (2.3%), ciprofloxacin (1.3%), and amikacin (0.9%).The authors of the study conclude that antimicrobial stewardship programs and regular monitoring for resistance could help minimize inappropriate prescribing for UTIs.Jun 25 J Glob Antimicrob Resist abstract FDA grants priority review for expanded indication for BaxdelaThe FDA has granted priority review status to a supplemental New Drug Application (sNDA) for the fluorquinolone antibiotic Baxdela (delafloxacin), according a news release from drug maker Melinta Therapeutics.The sNDA filing seeks to expand the indication for Baxdela, which was approved by the FDA in 2017 for use in patients with acute bacterial skin and skin structure infections, to include adult patients with community-acquired bacterial pneumonia (CABP). The application is based on the results of a phase 3 clinical trial that found that Baxdela had comparable efficacy to moxifloxacin for early clinical response and clinical outcome at test of cure in CABP patients, and was generally safe and well-tolerated. The drug has demonstrated effectiveness against gram-negative and gram-positive pathogens.”Baxdela’s potency and activity against the most common bacterial pathogens seen in CABP indicate it could play a significant role in the treatment of this life-threatening illness, if approved,” Melinta Chief Medical Officer Sue Cammarata, MD, said in the news release. “We look forward to working with the FDA to help evaluate bringing this potential option to people with CABP as soon as possible.”The FDA is expected to make a ruling on the sNDA by Oct 24, 2019.Jun 19 Melinta Therapeutics news releaselast_img