Oral gepotidacin for the treatment of uncomplicated urinary tract infection in Japanese female patients: a randomized, active reference, double-blind, double-dummy, Phase 3 trial (EAGLE-J)
Abstract
BACKGROUND
Two global Phase 3 trials, EAGLE-2 and EAGLE-3, found gepotidacin non-inferior (and superior in EAGLE-3) to nitrofurantoin for the treatment of uUTI in female participants, with an acceptable safety profile; however, these studies did not include Japanese centers.
METHODS
EAGLE-J (NCT05630833; jRCT2031220467) was a Phase 3, randomized, double-blind, active reference study evaluating the efficacy and safety of gepotidacin for the treatment of uUTI in Japan. Eligible participants were females aged ≥12 years with ≥2 uUTI symptoms and urinary nitrite or pyuria. Participants were randomly assigned (3:1) oral gepotidacin (1500 mg) or nitrofurantoin (100 mg) twice daily for 5 days. To bridge data, consistency of therapeutic response at test-of-cure (day 10-13) in the gepotidacin arm of EAGLE-J with EAGLE-2/EAGLE-3 was assessed in participants with qualifying nitrofurantoin-susceptible uropathogens (≥105 colony-forming units/mL). Therapeutic success comprised clinical (symptom resolution) and microbiological success (eradication). Consistency was claimed if the therapeutic success rate in EAGLE-J was greater than the consistency threshold predicted from EAGLE-2/EAGLE-3.
FINDINGS
Overall, the primary analysis included 108 participants (83 gepotidacin, 25 nitrofurantoin). At test-of-cure, gepotidacin therapeutic success was 83.1 % (69/83), exceeding the consistency threshold (48.2 %). Adverse events were mostly mild-to-moderate; common adverse events were diarrhea…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 108 participants or records.
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