Patients randomized to meropenem–vaborbactam received 7–14 days of treatment as monotherapy (2–2 g) via IV infusion over 3 h every 8 h. BAT included any of the following as monotherapy or in combination: polymyxins, carbapenems, aminoglycosides, or tigecycline; or monotherapy with ceftazidime-avibactam. Use of an aminoglycoside beyond 72 h in subjects with a pathogen(s) susceptible to meropenem–vaborbactam or ceftazidime-avibactam was considered a treatment failure. BAT was selected by the primary service and confirmed by the unblinded investigator according to institutional standards of care, patient characteristics (i.e., renal function, previous treatments, infection type, organism with corresponding MICs, etc.), and local regulatory approval. The choice of BAT regimen was left up to the investigator. Planned BAT was documented prior to randomization.
For patients with moderate-to-severe renal impairment (estimated creatinine clearance < 50 mL/min), meropenem–vaborbactam dose modifications were made (NCT02168946). BAT doses were adjusted according to local protocols.
For patients with moderate-to-severe renal impairment (estimated creatinine clearance < 50 mL/min), meropenem–vaborbactam dose modifications were made (NCT02168946). BAT doses were adjusted according to local protocols.
