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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title:

Brief 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

Detailed Summary:
Sponsor: Cempra Inc

Current Primary Outcome: Bacterial eradication of joint infection [ Time Frame: 3 to 6 months ]

Clinical success is defined as the absence of persistent infection in a patient who did not receive alternative antibiotic therapy targeting the infection.


Original Primary Outcome: Bacterial eradication of joint infection [ Time Frame: 12 weeks ]

Clinical success is defined as the absence of persistent infection as assessed by multiple second-stage surgery bacteriology cultures, in a patient who did not receive alternative antibiotic therapy targeting the joint infection.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Cempra Inc

Dates:
Date Received: December 18, 2012
Date Started: December 2012
Date Completion:
Last Updated: November 18, 2014
Last Verified: November 2014