- 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.
- 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%).
- 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.
- 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.