2024
A phase 3 randomized trial of sulopenem vs. ertapenem in patients with complicated intraabdominal infections
Dunne M, Aronin S, Das A, Akinapelli K, Breen J, Zelasky M, Puttagunta S. A phase 3 randomized trial of sulopenem vs. ertapenem in patients with complicated intraabdominal infections. Clinical Microbiology And Infection 2024 PMID: 39491784, DOI: 10.1016/j.cmi.2024.10.025.Peer-Reviewed Original ResearchComplicated intraabdominal infectionsIntraabdominal infectionsPhase 3 randomized trialErtapenem-treated patientsClinical success rateRandomized to 5Confidence intervalsNon-inferiority marginOral regimensAmoxicillin-clavulanateClinical responsePrimary endpointTreatment armsIsolated pathogensTreatment durationHospitalized adultsErtapenemB. fragilisPatientsSuccess rateSulopenemInfectionEndpointTreatment differencesDays
2023
2106. Desirability of Outcome Ranking (DOOR): Application to a Phase 3 Registrational Trial Evaluating Sulopenem for Patients with Complicated Intra-abdominal Infection (cIAI)
Aronin S, Dunne M, Gupta J, Puttagunta S. 2106. Desirability of Outcome Ranking (DOOR): Application to a Phase 3 Registrational Trial Evaluating Sulopenem for Patients with Complicated Intra-abdominal Infection (cIAI). Open Forum Infectious Diseases 2023, 10: ofad500.1730. PMCID: PMC10678622, DOI: 10.1093/ofid/ofad500.1730.Peer-Reviewed Original Research