Reports note steps for streamlining antibacterial clinical trials
A series of articles in a supplement to the latest issue of Clinical Infectious Diseases address what is termed a "crisis" in antibiotic development with recommendations to improve a critical stage in the process—clinical trials.
The journal supplement, titled "Facilitating Antibacterial Drug Development in a Time of Great Need," focuses on advancing and streamlining clinical trials, which are a critical part of the drug development process but which for antibiotics have become overly complicated, expensive, and lengthy to conduct. In particular, the supplement features articles that address the challenges of designing such trials for hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP), which are hampered by low enrollment, protocol complexities, and high costs.
The recommendations from the Clinical Trials Transformation Initiative (CTTI)—a public-private partnership that includes government officials, academics, and pharmaceutical industry executives—focus on four keys area areas that could improve HABP/VABP clinical trials: informed consent, protocol design, choice of institutional review board, and efficacy outcome measures. In another paper, CTTI offers suggestions to streamline the process of collecting safety data. These approaches will be tested in an upcoming pilot study.
"The need for new therapeutic and diagnostic options to address the public health crisis of antibiotic resistance and the need to modernize the design and conduct of clinical trials are international issues," Leanne Madre and Pamela Tenaerts of CTTI write in the introduction to the supplement. "Our hope is that the recommendations, activities, and ideas presented highlight the importance of public-private partnerships that are patient-centric and provide proof that streamlining HABP/VABP trials is possible."
Aug 2 Clin Infect Dis supplement
Drug-resistant Salmonella isolates identified in imported food products
A new study by the Food and Drug Administration has found antibiotic resistance in more than 20% of Salmonella enterica serovars isolated from food products imported into the US between 2011 and 2013.
The study, published this week in the Journal of Food Protection, found that 23 of 110 nontyphoidal S enterica (NTS) isolates showed resistance to various classes of antibiotics, including beta-lactams and fluoroquinolones, with 12 of the 23 showing resistance to more than three classes. One strain in particular was resistant to all antimicrobial agents tested except amoxicillin and clavulanic acid. The most common strains identified among the 23 drug-resistant isolates were S senftenberg and S enteritidis.
The contaminated food products included vegetables, fruits, meats, and seafood imported mainly from Southeast and East Asian countries. Drug-resistant NTS strains were predominantly found in products imported from Taiwan, Vietnam, Indonesia, and China.
According to the authors, NTS strains are considered the most common foodborne causes of gastroenteritis, enteric fever, diarrhea, and bacteremia. But only some NTS serovars are commonly associated with outbreaks. Serotyping NTS isolates is important for monitoring and tracking these pathogens, the researchers said, and this type of monitoring data could be used to improve food safety programs.
August J Food Prot abstract
