Gepotidacin (Blujepa) is safe and effective in women with uncomplicated urinary tract infections
1. Gepotidacin (Blujepa) leads to rapid clinical response in female patients with uncomplicated urinary tract infections (uUTIs) and is generally well-tolerated.
Evidence Rating Level: 2 (Good)
uUTIs are exceedingly common in women, with an incidence of 50% to 60%, and severely disrupt patients’ lives due to physical and mental burden. While antibiotic treatment is typically empiric, up to 17% of patients with uUTIs experience treatment failure. As antimicrobial resistance rises, so does the need for novel antibiotic agents. Gepotidacin is a novel, first-in-class triazaacenaphthylene oral antibacterial that inhibits bacterial DNA replication. While it has been approved in some countries for the treatment of uUTIs in specific populations, it is unclear how quickly patients experience improvement with gepotidacin. This phase 3b, open-label, single-arm, multicenter nonrandomized clinical trial included nonpregnant female patients 12 years or older with a body weight of 40 kg or more who presented with 2 or more clinical symptoms of uUTI (dysuria, frequency, urgency, or lower abdominal or suprapubic pain) and had evidence of urinary nitrites or pyuria. 97 patients (mean age [SD], 45.7 [16.4] years) received oral gepotidacin (1500 mg) twice daily for 5 days, and 90 patients (mean age [SD], 46.1 [16.4] years) were clinically evaluable. The clinical symptom score (CSS; range, 0-12), a composite of each uUTI symptom scored from 0-3 (higher = more severe), was assessed at 7 time points (0 hours, 24 hours, 48 hours, 72 hours, 96 hours, day 10, day 28). At 24 hours, 49 participants (54.4%; 95% CI, 43.6%-65.0%) in the clinically evaluable population had clinical symptom improvement. The number of participants with clinical symptom improvement at 48, 72, and 96 hours was 71 of 89 (79.8%; 95% CI, 69.9%-87.6%), 81 of 90 (90.0%; 95% CI, 81.9%-95.3%), and 77 of 89 (86.5%; 95% CI, 77.6%-92.8%), respectively. Clinical symptom resolution was 3 of 90 participants (3.3%) at 24 hours, 48 of 89 participants (53.9%) at 96 hours, and 81 of 90 (90.0%) at day 10. No participants required an additional nonstudy antimicrobial up to day 10. 58 adverse events (AEs) were experienced by 27 of the 97 participants (28%), with the most common being diarrhea (16 [16%]), flatulence (6 [6%]), dizziness (5 [5%]), abdominal pain (4 [4%]), headache (3 [3%]), abdominal discomfort (2 [2%]), and nausea (2 [2%]). There were no severe AEs, and three participants experienced drug-related AEs leading to study drug discontinuation.
Click here to read this study in JAMA Network Open
Image: PD
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