drugset / Trial / NCT02208063

A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial

NCT02208063 ↗

Phase 3 Terminated 121 enrolled Cumberland Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, randomized, open-label, noninferiority trial of telavancin versus standard IV therapy control (e.g., vancomycin, daptomycin, anti-staphylococcal penicillin (PCN), or cefazolin) in the treatment of subjects with complicated Staphylococcus aureus (S. aureus) bacteremia and SA right-sided infective endocarditis (SA-RIE).

Timeline

Start
2014-12
Primary completion
2018-04-12
Completion
2018-04-12

Outcome

Outcome not reported

Stopped: “Halted due to lack of statistical power. No safety concerns identified.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cefazolin Small molecule — Intravenous
Comparator Daptomycin Other / unclassified — Intravenous
Subject Telavancin Other / unclassified 7.5 mg/kg Intravenous
Comparator Vancomycin Other / unclassified — Intravenous
Comparator cloxacillin Other / unclassified — —
Comparator nafcillin Small molecule — —
Comparator oxacillin Small molecule — —