Phase II year
2021
(last award dollars: 2023)
Phase II Amount
$2,974,719
Rapid antimicrobial susceptibility testing directly from patient specimensEach year, 20 million patients are diagnosed with infections leading to over 100,000 deaths and costing the UShealthcare system about $70B. Antibiotic resistant infections are increasingly common, causing about 3 millioninfections and 35,000 deaths annually in the US. Patients, even those with life-threatening infections, can bequickly cured if, near the onset of infection, they can be treated with an antibiotic that specifically targets thepathogen causing the infection. Unfortunately, today's diagnostic methods require 2-4 days to determine tar-geted, or definitive, therapies. For this reason, physicians must treat patients empirically using broad-spectrumantibiotics that are often less effective than definitive treatments and sometimes even completely ineffective.Furthermore, treatment with these powerful drugs causes the spread of antibiotic resistance. This is exacerbatedby the fact that at least 30% of antibiotics are prescribed unnecessarily to patients that are in fact uninfected.Current antimicrobial susceptibility testing methods for determining the definitive therapies take days to deliverresults because they require multiple lengthy steps including a day-long step to purify the pathogen cells in largenumbers by microbiological culture. This proposal develops novel products that detect whether patients are in-fected, identify the pathogen in 30 minutes, and determine the definitive treatment in just a few hours ratherthan the days required today. The proposed tests thus have the potential to dramatically improve patient out-comes and attenuate the spread of resistance. The new tests identify (ID) pathogens and perform antimicrobialsusceptibility testing (AST) directly from patient specimens, eliminating the lengthy culture steps required by thecurrent methods. The novel MultiPath technology underlying the tests uses inexpensive digital imaging to rapidly,sensitively, and affordably count individual microscopic bacterial cells without magnification. The MultiPath ASTtests can determine the definitive treatment for a much broader range of infections than other emerging rapidsusceptibility methods because they can determine antimicrobial susceptibility for specimens with commensalbacteria and from patients with polymicrobial infections. The easy-to-use tests run on the automated random-access MultiPath analyzer that is currently under regulatory review. This Phase II proposal develops rapid ID andAST tests for urinary tract infections (UTIs). UTIs account for about half of all infections which are increasinglycaused by resistant pathogens. The proposed work builds on work presented in the preliminary results demon-strating the feasibility of AST directly from urine specimens. Specifically, we will (1) Complete UTI ID/AST productdevelopment; (2) Complete alpha UTI/AST analytical and preclinical studies; and (3) Complete external beta pre-clinical studies and prepare for regulatory submission. Completion of the proposed project will deliver MultiPathUTI ID/AST tests ready for verification and validation studies for regulatory submission in Phase III.
Public Health Relevance Statement: Narrative
We propose to develop products for determining effective antibiotic treatment for Urinary Tract Infections directly from
patient specimens in hours rather than the days required for today's methods. The proposed automated test will for the
first time enable near-patient pathogen identification and antimicrobial susceptibility testing inside and outside of the
hospital. The proposed test promises to improve patient outcomes, decrease inappropriate antibiotic treatment, and
lower healthcare costs.
Project Terms: |
