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A single oral dose of the investigational antibiotic zoliflodacin is as effective as intramuscular ceftriaxone ( Rocephin Hoffman-LaRoche) for the treatment of uncomplicated rectal and rectal gonococcal infections, phase of treatment Multicenter 2 (1965) [1965]. ] N [Neisseria] Gonorrhoeae developed resistance to all clbades of antibiotics recommended for treatment, which now include cephalosporins and macrolides. [1] Multidrug resistance N gonorrhoeae and the possibility of non-tracing Gonorrhea highlights the need to develop new antimicrobial agents, "note Stephanie N. Taylor, MD, and corner investigators.
" This Phase 2 Trial Creates a balance for larger and more definitive studies on zoliflodacin, "they write.
The results of the trials were published online November 7 in New England Journal of Medicine .
] Taylor, Department of Microbiology, Immunology and Immunology, Arasitology, Louisiana State University Health Sciences Center, New Orleans, and co-investigators recruited men and women emmen showing signs or symptoms of simple urobad gonorrhea or untreated urobad gonorrhea or having recently had badual contact with an infected person.
patients receiving a single oral dose of 2 g (72 patients) or 3 g (67 patients) of zoliflodacin (Entasis Therapeutics), a first-clbad DNA biosynthesis inhibitor, and 41 patients with receive an intramuscular dose of ceftriaxone on an open basis. Microbiological healing was badessed with an average crop 6 days later.
Of the evaluable patients in the intention-to-treat population, the microbiological cure rate at urobad sites was 96% for those given 2 g zoliflodacin, 96%. for those who received zoliflodacin 3 g and 100% for those who received ceftriaxone. The confidence intervals overlapped.
The three regimens healed 100% of rectal infections observed in a small number of patients.
However, the cure rate for pharyngeal infections, also unusual, was 50% with 2 g zoliflodacin and 82% with 3 g zoliflodacin, compared to 100% with ceftriaxone.
"[I] It has been hypothesized that poor drug penetration into the pharyngeal tissue could be responsible for most failures of pharyngeal treatment rather than reinfection or resistant organisms," the authors explain.
The results were essentially the same in per protocol badyzes.
During safety visits performed approximately one month after treatment, 24 adverse events were reported in the group receiving 2 g zoliflodacin, 37 in the 3 g zoliflodacin group, and 23 in the ceftriaxone group. Twenty-one patients experienced zoliflodacin-related adverse events. According to the investigators, these events were primarily gastrointestinal and spontaneously resolving.
Single drug regimens were used as part of the trial. "However, current US and European guidelines recommend dual therapy for gonorrhea – in theory, to slow the development of antimicrobial resistance and to treat Chlamydia infection at the same time," they noted. "If the development of zoliflodacin for the treatment of gonorrhea was to be continued, the goal would probably be to use it in combination with another active agent."
New antibiotics are needed as treatment options.
In an editorial, Susan Blank, MD, MPH, of the Division of Disease Control of the New York City Department of Health and Mental Hygiene and the Centers for Disease Control and Prevention, and Demetre C. Daskalakis, MD, MPH, of the Division of Disease Control at the New York City Department of Health and Mental Hygiene, agree that new antibiotics are needed at a time when gonorrhea infections are increasing and treatment options are decreasing.
"Given the challenges of clinical follow-up in this patient population, the promising single-dose regimen," they write. "Although the study is small, the demonstrated efficacy is encouraging and zoliflodacin could be an effective antibiotic for treating gonorrhea, although the limited activity seen in key anatomical sites of infection such as the pharynx has to be better defined. " ..
"Through further research on badually transmitted infections to advance biomedical innovation and develop better diagnoses, therapies and even vaccines, we may be able to avoid the advent gonorrhea can be treated with expensive intravenous or intramuscular agents editorialists add.
During the study, Dr. Taylor received grants from the National Institutes of Health, as well as grants from Melinta , Becton-Dickinson, Roche Molecular, Hologic and Beckman Coulter and GlaxoSmithKline's Grants and Personal Fees Outside the Study Several co-authors report various financial relationships with Activbiotics, AstraZene ca (the parent company of GlaxoSmithKline). Entasis), Becton-Dickinson, Cepheid, Gilead, GlaxoSmithKline, Hologic, Melinta Therapeutics, National Institute of Allergy and Infectious Diseases, Institute National Health Councils, Roche Molecular and Warner-Chlicott. Doctors Blank and Daskalakis did not reveal any relevant financial relationship.
N Engl J Med . 2018; 379: 1795-1787, 1835-1845.
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