What are investigational treatments for gonorrhea?

Updated: Sep 07, 2018
  • Author: Brian Wong, MD; Chief Editor: Pranatharthi Haran Chandrasekar, MBBS, MD  more...
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Answer

In a clinical trial conducted by the CDC and NIH, 2 new antibiotic regimens successfully treated gonorrhea infections. The 2 regimens consist of gentamicin IV plus azithromycin PO, and gemifloxacin PO plus azithromycin PO. The study was conducted to identify new treatment options in the face of growing antibiotic resistance. [67, 68] While the study results offer successful treatment options, the CDC is not recommending a change in current guidelines due to the severe gastrointestinal side effects reported by trial participants. However, providers may consider using the regimens studied in this trial as alternative options when ceftriaxone cannot be used. [69]

The study of these antibiotic regimens included 401 men and women ranging in age from 15 years to 60 years. The combination treatments were highly effective in curing genital gonorrhea infections. The gentamicin plus azithromycin was found to be 100% effective and the gemifloxacin plus azithromycin was 99.5% effective. Both combinations cured 100% of gonococcal infections of the throat and rectum. [67, 68]

Although highly effective, the regimens frequently caused adverse GI effects. Of the 202 participants in the gentamicin plus azithromycin arm, 28% experienced nausea, 19% experienced diarrhea, and 7% experienced either abdominal discomfort/pain or vomiting. Of the 199 participants in the gemifloxacin plus azithromycin arm, 37% experienced nausea, 23% experienced diarrhea, and 11% experienced abdominal discomfort/pain. [67, 68]

Because of the emergence of multi-drug resistant (MDR) and extensively drug-resistant (XDR) N gonorrhoeae, combinations of available medications have been tested to maximize treatment response. Two combinations showed some promise in vitro: (1) gentamicin plus ertapenem and (2) gentamicin plus cefixime. Further investigation of these two combination regimens for treatment of drug-resistant gonorrhea is necessary prior to mainstream use. [70]

The novel experimental oral antibiotic ETX0914 (Entasis Therapeutics) was found to be safe and efficacious in treating uncomplicated urogenital gonorrhea in a phase 2 clinical trial. The FDA has designated ETX0914 a Qualified Infectious Disease Product and awarded the drug fast-track status. [26]


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