title: A Phase 2 Trial of Oral Solithromycin 1200 mg or 1000 mg as Single-Dose Oral Therapy for Uncomplicated Gonorrhea.
abstract: BACKGROUND
  Progressive resistance to antimicrobial agents has reduced options for gonorrhea therapy worldwide. Solithromycin (CEM-101) is a novel oral fluoroketolide antimicrobial with substantial in vitro activity against Neisseria gonorrhoeae.
  
  
  METHODS
  We conducted a phase 2 trial of 2 oral doses of solithromycin (1200 and 1000 mg) for treatment of uncomplicated gonorrhea.
  
  
  RESULTS
  A total of 59 participants were enrolled and treated in this trial; 28 participants received 1200 mg of solithromycin and 31 received 1000 mg. Forty-six (78%) participants had positive cultures for N. gonorrhoeae at the time of enrollment: 24 of the 28 persons (86%) who received 1200 mg of oral solithromycin, and 22 of 31 (71%) who received 1000 mg. In addition, 8 participants had positive pharyngeal gonococcal cultures, and 4 had positive rectal cultures. All patients with positive cultures for N. gonorrhoeae were cured at all sites of infection. Chlamydia trachomatis and Mycoplasma genitalium coinfections were evaluated using nucleic acid amplification tests and were negative at 1 week of follow-up in 9 of 11 (82%) participants positive for C. trachomatis and 7 of 10 (70%) participants positive for M. genitalium. Mild dose-related gastrointestinal side effects (nausea, loose stools, vomiting) were common but did not limit therapy.
  
  
  CONCLUSIONS
  Oral single-dose solithromycin, in doses of 1000 mg and 1200 mg, was 100% effective for treatment of culture-proven gonorrhea at genital, oral, and rectal sites of infection and is a promising new agent for gonorrhea treatment.
  
  
  BACKGROUND
  NCT01591447.
authors.affiliation: University of Alabama at Birmingham.
authors.forename: Edward W
authors.initials: EW
authors.lastname: Hook
authors.affiliation: University of Washington, Seattle.
authors.forename: Matthew
authors.initials: M
authors.lastname: Golden
authors.affiliation: Cempra Inc, Chapel Hill, North Carolina.
authors.forename: Brian D
authors.initials: BD
authors.lastname: Jamieson
authors.affiliation: University of Alabama at Birmingham.
authors.forename: Paula B
authors.initials: PB
authors.lastname: Dixon
authors.affiliation: University of Alabama at Birmingham.
authors.forename: Hanne S
authors.initials: HS
authors.lastname: Harbison
authors.affiliation: University of Washington, Seattle.
authors.forename: Sylvan
authors.initials: S
authors.lastname: Lowens
authors.affiliation: Cempra Inc, Chapel Hill, North Carolina.
authors.forename: Prabhavathi
authors.initials: P
authors.lastname: Fernandes
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D024881:Drug Resistance, Bacterial; D005260:Female; D006069:Gonorrhea / Q000188:drug therapy* / Q000382:microbiology; D006801:Humans; D018942:Macrolides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009344:Neisseria gonorrhoeae / Q000187:drug effects; D014230:Triazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D018942:Macrolides; D014230:Triazoles; C547755:solithromycin
keywords: STDs; antibiotic resistance; gonorrhea; solithromycin