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

Infected Spacers Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01756924
• Other study ID #: CE06-200
• Status: Terminated
• Phase: Phase 2
• Start date: December 2012
• Est. completion date: July 2014

Study information

• Verified date: April 2019
• Source: Arrevus Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Infected Spacers
• Infection
• Prosthetic Joint Infections of Hip
• Prosthetic Joint Infections of Knee

Intervention

Drug:
• CEM-102

• IV or Oral standard of care antibiotics

• Rifampin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Arrevus Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial eradication of joint infection	Clinical success is defined as the absence of persistent infection in a patient who did not receive alternative antibiotic therapy targeting the infection.	3 to 6 months