drugset / Trial / NCT01756924

Safety and Efficacy of CEM-102 With Rifampin Compared to Standard Therapy in Patients With Prosthetic Joint Infections or Spacer Infection

NCT01756924

Phase 2 Terminated 14 enrolled Arrevus Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

To determine if oral antibiotic treatment with CEM-102 and Rifampin is as effective and safe as the standard of care antibiotic therapy for the treatment of hip and knee prosthetic joint or spacer infections

Timeline

Start
2012-12
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Fusidic Acid Unknown Oral
Subject Rifampin Small molecule Oral
Comparator Cefazolin Small molecule Intravenous
Comparator Ceftaroline Other / unclassified Intravenous
Comparator Ceftriaxone Other / unclassified Intravenous
Comparator Ciprofloxacin Small molecule Intravenous
Comparator Daptomycin Other / unclassified Intravenous
Comparator Levofloxacin Small molecule Intravenous
Comparator Linezolid Other / unclassified Intravenous
Subject Rifampin Small molecule Intravenous
Comparator Vancomycin Other / unclassified Intravenous
Comparator nafcillin Small molecule Intravenous
Comparator oxacillin Small molecule Intravenous
Comparator trimethoprim-sulfamethoxazole Unknown Intravenous