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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

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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
Sponsor:
Information provided by (Responsible Party):
Arrevus Inc.

Tracking Information
First Submitted Date  ICMJE December 18, 2012
First Posted Date  ICMJE December 28, 2012
Last Update Posted Date April 19, 2019
Study Start Date  ICMJE December 2012
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2013)
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 Measures  ICMJE
 (submitted: December 20, 2012)
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.
Change History Complete list of historical versions of study NCT01756924 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of CEM-102 With Rifampin Compared to Standard Therapy in Patients With Prosthetic Joint Infections or Spacer Infection
Official Title  ICMJE Not Provided
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prosthetic Joint Infections of Hip
  • Prosthetic Joint Infections of Knee
  • Infected Spacers
Intervention  ICMJE
  • Drug: CEM-102
    Other Name: fusidic acid
  • Drug: IV or Oral standard of care antibiotics
    Other Names:
    • vancomycin
    • daptomycin
    • linezolid
    • rifampin
    • ceftriaxone
    • cefazolin
    • ceftaroline
    • nafcillin
    • oxacillin
    • ciprofloxacin
    • levofloxacin
    • co-trimoxazole
  • Drug: Rifampin
Study Arms  ICMJE
  • Experimental: CEM-102 plus Rifampin
    Interventions:
    • Drug: CEM-102
    • Drug: Rifampin
  • Active Comparator: Standard of Care
    Intervention: Drug: IV or Oral standard of care antibiotics
Publications * Pushkin R, Iglesias-Ussel MD, Keedy K, MacLauchlin C, Mould DR, Berkowitz R, Kreuzer S, Darouiche R, Oldach D, Fernandes P. A Randomized Study Evaluating Oral Fusidic Acid (CEM-102) in Combination With Oral Rifampin Compared With Standard-of-Care Antibiotics for Treatment of Prosthetic Joint Infections: A Newly Identified Drug-Drug Interaction. Clin Infect Dis. 2016 Dec 15;63(12):1599-1604. Epub 2016 Sep 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 9, 2014)
14
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2012)
50
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01756924
Other Study ID Numbers  ICMJE CE06-200
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arrevus Inc.
Study Sponsor  ICMJE Arrevus Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Arrevus Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP