- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Three NIH-Sponsored Trials Test Flu Treatments
Researchers seek more effective therapies (Feb. 5)
Three clinical studies aimed at finding more effective treatments for influenza are enrolling volunteers with the flu at the National Institutes of Health (NIH) in Bethesda, Md., and at several dozen other domestic and international sites.
One study examines whether treatment with a licensed influenza drug, oseltamivir, reduces the time that infected people continue to produce virus in the upper airway.
A second tests whether a combination of three licensed flu antiviral drugs works better than oseltamivir alone in people with influenza who have chronic health conditions, such as heart or lung disease, that put them at greater risk of severe illness.
The third tests whether treatment with plasma enriched with anti-influenza antibodies improves the condition of hospitalized flu patients compared with standard antiviral treatment alone.
The studies are sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. Investigators at 36 sites in the U.S. and at additional sites in Argentina, Australia, Mexico, and Thailand are participating.
Although oseltamivir has been approved for use in the U.S. since 1999, no studies have shown conclusively whether the drug significantly reduces the amount of virus produced (shed) by an infected person. Reduced shedding would likely lessen the chances of an infected person passing the virus to others. The oseltamivir trial will enroll approximately 560 people aged 18 to 65 years in the U.S., Argentina, and Thailand.
The trial comparing oral oseltamivir alone with oseltamivir plus two other licensed antiviral drugs is enrolling up to 720 adults in the U.S., Argentina, Australia, Mexico, and Thailand. In addition to having laboratory-confirmed influenza, enrollees must have at least one other characteristic that places them at increased risk of developing serious complications. Asthma and other lung disorders, heart disease, obesity, weakened immune function, and being over age 65 are some of the conditions that place people at higher risk for serious disease.
The third trial is enrolling children as well as adults, including pregnant women, hospitalized with severe influenza. This trial aims to enroll approximately 100 people at sites in the U.S. All participants will receive standard drug treatment for influenza, and half will also receive two infusions of plasma enriched with antibodies against the virus.
Source: NIH; February 5, 2013.