EAGLE-1
Trial question
Is oral gepotidacin noninferior to intramuscular ceftriaxone plus azithromycin in patients with uncomplicated urogenital gonorrhea?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
8.0% female
92.0% male
N = 406
406 patients (34 female, 372 male).
Inclusion criteria: patients aged ≥ 12 years with uncomplicated urogenital gonorrhea.
Key exclusion criteria: male patients with a current diagnosis of epididymitis and/or orchitis; C. trachomatis infection if treatment could not be postponed; BMI ≥ 40 kg/m² or BMI ≥ 35 kg/m² and obesity-related health conditions; sensitivity to study treatments; immunocompromised state or altered immune defense that may predispose to higher risk of treatment failure and/or complications; uncompensated HF; severe LVH.
Interventions
N=202 gepotidacin (two doses of 3,000 mg PO, administered 10-12 hours apart).
N=204 ceftriaxone plus azithromycin (ceftriaxone 500 mg IM plus azithromycin 1 g PO).
Primary outcome
Microbiological success
92.6%
91.2%
92.6 %
69.4 %
46.3 %
23.1 %
0.0 %
Gepotidacin
Ceftriaxone plus
azithromycin
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in microbiological success (92.6% vs. 91.2%; AD -0.1%, 95% CI -5.6 to 5.5).
Safety outcomes
No significant difference in serious adverse events.
Significant difference in treatment-emergent adverse events (74.4% vs. 33.2%).
Conclusion
In patients aged ≥ 12 years with uncomplicated urogenital gonorrhea, gepotidacin was noninferior to ceftriaxone plus azithromycin with respect to microbiological success.
Reference
Jonathan D C Ross, Janet Wilson, Kimberly A Workowski et al. Oral gepotidacin for the treatment of uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3 randomised, open-label, non-inferiority, multicentre study. Lancet. 2025 May 3;405(10489):1608-1620.
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