Gonorrhea: solithromycin fails to reach noninferiority margin in phase 3

  • Chen MY et al
  • Lancet Infect Dis 2019

  • International Clinical Digest
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Takeaway

  • Single-dose, 1000 mg oral solithromycin failed to demonstrate noninferiority to intramuscular (IM) ceftriaxone/oral azithromycin for first-line alternative treatment of uncomplicated, genital gonorrhea.

Why this matters

  • Continue to treat urogenital gonorrhea with ceftriaxone/azithromycin as per CDC guidelines.

Key results

  • 261 patients (130 solithromycin, 131 ceftriaxone/azithromycin).
  • At test of cure, 80% (99/123) with solithromycin vs 84% (109/129) with ceftriaxone/azithromycin had genital Neisseria gonorrhoeae eradication (difference, −4.0%; 95% CI, −13.6% to 5.5%).
  • Genital gonorrhea persistence: 7% (8/123) with solithromycin vs 0% with ceftriaxone/azithromycin.
  • All patients with genital treatment failure at day 7 were men with persistent urethral infections.
  • Adverse events were more common with solithromycin (53% [69/130] vs 34% [45/131]) and consisted primarily of diarrhea (24% vs 15%) and nausea (21% vs 11%).

Study design

  • Phase 3, open-label, multicenter, noninferiority study of oral solithromycin 1000 mg vs IM ceftriaxone 500 mg/oral azithromycin 1000 mg in patients aged ≥15 years with uncomplicated, untreated genital gonorrhea.
  • Funding: Cempra Pharmaceuticals.

Limitations

  • Treatment failure included patients lost to follow-up.
  • No prespecified superiority testing level.
  • Active drug used as monotherapy.
  • Culture-only confirmed infection, cure.
  • Greater proportion of males.