FDA Approves Test to Determine the Need for Antibiotics in Certain Infections

FDA Approves Test to Determine the Need for Antibiotics in Certain Infections

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Highlights:
  • Bacterial infections often require treatment with antibiotics, while antibiotics are ineffective in viral infections
  • A test to differentiate between bacterial and viral infection has recently been approved for use in lower respiratory tract infections and sepsis so that the appropriate treatment can be started or stopped
  • The test, however, can generate false negative or false positive results
The U.S. Food and Drug Administration has approved the use of the Vidas Brahms PCT Assay in lower respiratory tract infections and sepsis to determine the need for antibiotics in these patients in the hospital or emergency room.
FDA Approves Test to Determine the Need for Antibiotics in Certain Infections

The misuse of antibiotics is an ongoing problem. There are people who take antibiotics in inappropriate doses or for stunted durations. This leads to superbugs (bacteria that are resistant to antibiotics) - resulting in available medications becoming ineffective.

Viral and bacterial infections often produce similar symptoms. Viral infections do not respond to antibiotics, while bacterial infections do. Sometimes, when the patient is serious and the diagnosis is unclear, doctors start antibiotics and then change the treatment once results of culture and sensitivity tests are available.

The Vidas Brahms PCT Assay is a test that can help to differentiate between bacterial and viral infection. The test measures a protein in the blood called procalcitonin.

High levels of procalcitonin in the blood indicate the presence of a bacterial infection, and also reflect the severity of the infection. The levels come down following treatment with antibiotics. Low levels of procalcitonin may indicate viral or non-infectious causes, which do not require antibiotics.

The US FDA has approved the use of the Vidas Brahms PCT Assay to determine if antibiotics can be started or stopped in patients with lower respiratory tract infections like community-acquired pneumonia, or stopped in patients with sepsis, a serious bacterial infection that can result in organ failure and even death. Both these conditions can have serious consequences.

The test gives the result in 20 minutes, unlike the culture and sensitivity test, which could even take a few days. However, unlike the culture and sensitivity test, this test does not indicate the causative bacteria or the antibiotic that the bacteria will be sensitive to.

This test could be useful to reduce the use of antibiotics in patients with serious infections without adversely affecting the patient outcomes. It could reduce the side effects as well as the cost of treatment with antibiotics.

Like most other tests, this test can also generate false positive or false negative results. A false positive result means that the test will indicate the presence of a bacterial infection when it is not present. As a result, antibiotics may be unnecessarily used in these patients. False negative means that a bacterial infection may be present, but the test indicates that it is absent. As a result, the treatment with antibiotics may be delayed and could result in serious consequences. Therefore, like with any other test result, the patient's clinical condition should also be assessed while evaluating the result of the test and deciding on the course of treatment.

Reference:
  1. FDA clears test to help manage antibiotic treatment for lower respiratory tract infections and sepsis - (https:www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm543160.htm)


Source: Medindia

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