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O02.5 A Phase II, Dose Ranging Study to Evaluate the Efficacy and Safety of Single-Dose Oral Solithromycin (CEM-101) For Treatment of Patients with Uncomplicated Urogenital Gonorrhoea
  1. E W Hook III1,
  2. B D Jamieson2,
  3. D Oldach2,
  4. H Harbison1,
  5. A Whittington1,
  6. P Fernandes2
  1. 1University of Alabama at Birmingham, Birmingham, AL, United States
  2. 2Cempra Pharmaceuticals, Chapel Hill, NC, United States

Abstract

Objectives Emerging resistance to available treatment creates an urgent need for new therapies for uncomplicated gonorrhoea. Solithromycin, a new 4th generation macrolide with 3 ribosomal targets, is highly active against most antibiotic-resistant strains of Neisseria gonorrhoeae. A Phase II, dose ranging study to evaluate the efficacy and safety of single-dose oral solithromycin for uncomplicated urogenital gonorrhoea was conducted.

Methods Consenting participants with suspected Neisseria gonorrhoeae infection were cultured at the urethra/cervix, rectum, and pharynx at enrollment and Day 7 . The primary outcome was bacterial eradication (conversion from positive baseline N. gonorrhoeae urethral/cervical culture to negative) at Day 7. Secondary outcomes included eradication of rectal or pharyngeal gonorrhoea and the eradication of gonococcal and chlamydial nucleic acids. Initially, eligible patients received a single 1200 mg oral dose of solithromycin; following demonstration of bacteriologic efficacy, a second cohort was treated with a single 1000 mg dose.

Results Of 41 (19 M, 22 F) participants enrolled, 28 were treated with a 1200 mg dose and, to date, 13 with 1000 mg. Gonococcal eradication rates in 22 evaluable 1200 mg patients were 100% (22/22) for urethral/cervical, pharyngeal (5/5), and rectal (2/2) infections. Of 9 evaluable 1000 mg patients enrolled to date, gonococcal eradication rates have been 100% (9/9) for urethral/cervical, pharyngeal (2/2), and rectal (1/1) infections. Susceptibility data from 25 isolates show the median MIC (range) for solithromycin was 0.06 µg/mL (0.015–0.125) and for azithromycin was 0.125 µg/mL (0.06–0.5).

Solithromycin was generally well-tolerated with mild dose-related gastrointestinal AEs (68%; 28/41). The most common AE was mild diarrhoea, occurring in 61% (17/28) of patients receiving the 1200 mg dose and 15% (2/13) of patients receiving the 1000 mg dose.

Conclusions A single dose of 1200 or 1000 mg solithromycin appears to be well-tolerated and effective in eradicating N. gonorrhoeae.

  • clinical trial
  • gonorrhea
  • macrolide

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