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

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

Inclusion Criteria:

• Prosthetic knee or hip joint infection
• Infected joint spacer
• Able to swallow tablets
• Able to voluntarily sign the informed consent form
• Females of childbearing potential must use an acceptable method of birth control
• The joint infection must be attributed to bacterial pathogens sensitive to fusidic acid and rifampin

Exclusion Criteria:

• History of hypersensitivity or intolerability to sodium fusidate (Fucidin®), or to rifampin
• Females who are pregnant or lactating
• Requirement for significant immunosuppression
• Bacteremia
• Known cirrhosis or decompensated liver disease
• Current treatment for HIV or Hepatitis C
• Seizure disorder, requiring anti-convulsants