The overuse of antibiotics over the last 70 years has created drug resistant bacteria that have adapted, making antibiotics less effective. Community acquired pneumonia patients seen in the emergency room are prescribed powerful, broad-spectrum antibiotics an estimated 30 times more than necessary. Not only does this lead to the creation of antibiotic resistant bacteria, but causes unnecessary hospital admissions and increases length of stay in the hospital. Long term adverse health consequences for the patient prescribed broad-spectrum antibiotics include reinfection with resistant bacteria and imbalances of beneficial gut flora, which can lead to chronic diarrhea from C. difficile. The CDC and medical societies such as IDSA and SHEA are actively engaged in driving initiatives to combat drug-resistant bacteria and enhance antibiotic stewardship. In 2017, CMS will mandate that hospitals implement antibiotic stewardship programs. Hospitals and long term healthcare facilities are in need of new tools to replace current empiric protocols and guide more effective antibiotic prescribing and de-escalation.

The team at Avisa Pharma, Inc. is confronting this problem by developing a rapid, point-of-care, urea breath test to determine if a pneumonia patient has one of these superbugs and to aid clinical decision making on use and choice of antibiotics. Avisa is a venture-backed company with patented technology to detect certain lung pathogens in breath. The Avisa breath test is targeted at emergency rooms, hospital wards and intensive care units where serious cases of pneumonia are seen and antibiotic resistant bacteria are more likely to be present.

To conduct a test, the patient provides a baseline breath sample and then inhales a proprietary, nebulized mist of 13C-labeled urea. After this mist is inhaled a second breath sample is collected and 13CO2 in the second sample is compared to the baseline sample to determine if the patient’s lungs are infected with pathogens that metabolize urea. The Avisa breath test has the advantages of being noninvasive, simple to administer and provides an answer at the point of care in 10 minutes. The Avisa breath test will give the doctor critical information regarding the type of infection causing the pneumonia and will lead to more appropriate use of powerful, broad spectrum antibiotics, decreased hospital admissions and decreased hospital length of stay, and less long term health consequences from overuse of powerful, broad-spectrum antibiotics.

The Avisa BreathTestTM is currently an investigational device and has not yet been approved by the FDA for commercial use.