Scientists have found that a single-dose of the oral antibiotic zoliflodacin successfully treated uncomplicated genital infections caused by gonorrhea, according to research published in The New England Journal of Medicine.
The study is important because it offers the possibility of a single-dose oral treatment for this infection; the U.S. Centers for Disease Control and Prevention (CDC) now recommends an injection of the only currently available antibiotic that will reliably treat gonorrhea — ceftriaxone. The trial was funded by the National Institute of Allergy and Infectious Diseases.
Jeanne Marrazzo, M.D., division director of the University of Alabama at Birmingham Division of Infectious Diseases, and Edward Hook III, M.D., professor in the Division of Infectious Diseases, were contributing authors.
“Since 2013, gonorrhea rates in the United States have increased by 67 percent, and it’s imperative that we discovered a reliable and affordable oral treatment option, as the bacteria has become increasingly antibiotic-resistant,” Marrazzo said. “As researchers and clinicians, we are excited that zoliflodacin offers a viable treatment option for the majority of uncomplicated urogenital and rectal gonococcal infections.”
In the multiple-center, phase 2 trial, 179 randomly assigned men and women who presented with signs and symptoms of uncomplicated and untreated gonorrhea or who had sexual contact with a person who had gonorrhea within the previous 14 days were enrolled. Participants were randomly assigned to a single 2g or 3g dose of zoliflodacin, or to the current standard of care, a single 500mg intramuscular dose of ceftriaxone, for comparison.
Microbiologic cure at the urogenital site was documented in 96 percent of participants who received 2g of zoliflodacin, 96 percent who received 3g of zoliflodacin, and 100 percent who received ceftriaxone. All rectal infections were cured with 2g and 3g doses of zoliflodacin and all who received ceftriaxone.
|“To have an oral treatment option available is certainly game-changing and has the ability to help gonorrheal patients moving forward.”|
One area where zoliflodacin was less effective was in the treatment of pharyngeal infections, as compared to ceftriaxone.
“What these findings tell us is that, in most instances where the case of gonorrhea is uncomplicated, zoliflodacin can be a recommended treatment option,” Hook said. “To have an oral treatment option available is certainly game-changing and has the ability to help gonorrheal patients moving forward.”
In addition to UAB, Louisiana State University Health Sciences Center, the University of Washington, Indiana University and the University of North Carolina recruited participants.
UAB’s Sexually Transmitted Diseases Research Program has played a leadership role in helping to treat persons with and at risk for STIs through its many years of participation in evaluation of new diagnostic tests and treatment options.