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

Phase 2

Terminated

• Conditions: Prosthetic Joint Infections of Knee; Infected Spacers; Prosthetic Joint Infections of Hip
• Interventions: Drug: CEM-102; Drug: IV or Oral standard of care antibiotics; Drug: Rifampin

• Registration Number: NCT01756924
• Lead Sponsor: Arrevus Inc.

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 Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-20
• Study First Posted: 2012-12-28
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Disposition First Submitted: 2014-11-06
• Disposition First Submitted QC: 2014-11-18
• Disposition First Posted: 2014-12-03
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CEM-102 plus Rifampin	CEM-102	-
Standard of Care	IV or Oral standard of care antibiotics	-
CEM-102 plus Rifampin	Rifampin	-

Primary Outcome Measures

Name	Time	Method
Bacterial eradication of joint infection	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.