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

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arrevus Inc.; Cempra Inc
• Treatments: Anti-Bacterial Agents; Cefazolin; Ceftriaxone; Ciprofloxacin; Daptomycin; Fusidic Acid; Levofloxacin; Linezolid; Nafcillin; Oxacillin; Rifampin; Trimethoprim, Sulfamethoxazole Drug Combination; Vancomycin

Criteria

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