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

Stopped early · Phase 2

Conditions studied: Prosthetic Joint Infections of Hip, Prosthetic Joint Infections of Knee, Infected Spacers

In brief

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

Key facts

Study ID

NCT01756924

Run by

Arrevus Inc.

People needed

14

Starts

2012-12-01

Expected to finish

2014-07-01

Last updated by the study team

2019-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Sarasota, Florida, United States
• Study site — Tamarac, Florida, United States
• Study site — Savannah, Georgia, United States
• Study site — Baltimore, Maryland, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Syracuse, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Houston, Texas, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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