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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01756924
Recruitment Status : Terminated (This study has been terminated; alternative study designs are being considered. Fusidic acid remains available under an Expanded Access Protocol.)
First Posted : December 28, 2012
Last Update Posted : April 19, 2019
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Prosthetic Joint Infections of Hip Prosthetic Joint Infections of Knee Infected Spacers Drug: CEM-102 Drug: IV or Oral standard of care antibiotics Drug: Rifampin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Rifampin

Arm Intervention/treatment
Experimental: CEM-102 plus Rifampin Drug: CEM-102
Other Name: fusidic acid

Drug: Rifampin
Active Comparator: Standard of Care Drug: IV or Oral standard of care antibiotics
Other Names:
  • vancomycin
  • daptomycin
  • linezolid
  • rifampin
  • ceftriaxone
  • cefazolin
  • ceftaroline
  • nafcillin
  • oxacillin
  • ciprofloxacin
  • levofloxacin
  • co-trimoxazole

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756924

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United States, Florida
Sarasota, Florida, United States, 34232
Tamarac, Florida, United States, 33321
United States, Georgia
Savannah, Georgia, United States, 31419
United States, Maryland
Baltimore, Maryland, United States, 21215
Baltimore, Maryland, United States, 21218
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, New York
Syracuse, New York, United States, 13507
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Houston, Texas, United States, 77030
Houston, Texas, United States, 77043
Sponsors and Collaborators
Arrevus Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Arrevus Inc.
ClinicalTrials.gov Identifier: NCT01756924    
Other Study ID Numbers: CE06-200
First Posted: December 28, 2012    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Keywords provided by Arrevus Inc.:
prosthetic joint infection
hip arthroplasty
knee arthroplasty
Additional relevant MeSH terms:
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Communicable Diseases
Arthritis, Infectious
Disease Attributes
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Anti-Bacterial Agents
Trimethoprim, Sulfamethoxazole Drug Combination
Fusidic Acid
Anti-Infective Agents
Antibiotics, Antitubercular
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors