Eagle 2
A new antibiotic for the treatment of uncomplicated Urinary Tract Infection ( UTI) in female adults and adolescents sponsored by GSK .
Overview / Background
There has been no new class of antibiotics for over 20 years . Gepotidacin is a novel ‘first in class’ bactericidal antibiotic that inhibits DNA replication by a distinct mechanism of action and may potentially help to combat antimicrobial resistance.
Process
The Eagle 2 Study compares the efficiency and safety of gepotidacin (1500mg administered twice daily for 5 days) to nitrofurantoin ( 100mg administered twice daily for 5 days) . The Primary End-point is the combined clinical and microbiological response at the Test of Cure (TOC) visit in patients with qualifying uropathogens ( or bacteria)
Additional Information
This trial is now closed to recruitment. Enrolment ceased early following a recommendation by the independent Data Montitoring Committee ( IDMC) based on a pre-specified interim analysis of efficacy and safety data in over 3000 patients across Eagle 2 and Eagle 3 Trials . The IDMC Review did not identify any safety concerns . Final publication of findings is awaited.
Participant Requirements
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