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Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections

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: NCT02569541
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Arrevus Inc.

Tracking Information
First Submitted Date  ICMJE October 5, 2015
First Posted Date  ICMJE October 6, 2015
Last Update Posted Date April 17, 2019
Study Start Date  ICMJE December 2015
Actual Primary Completion Date October 17, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
Clinical success at 6 months [ Time Frame: 6 months after start of treatment ]
Proportion of subjects in the intent to treat (ITT) analysis set who meet all the criteria for clinical success at the 6-Month Visit.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02569541 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
  • Safety and tolerability [ Time Frame: Entire study period - up to 24 months ]
    Incidences of TEAEs, SAEs, deaths, and discontinuations due to AEs, clinical laboratory evaluations
  • Clinical success at later time points [ Time Frame: 9 to 24 months after start of treatment ]
    The proportion of subjects in the ITT analysis set who meet all the criteria for clinical success, as defined above, at the 9-Month, 12-Month, 15-Month, 18-Month, 21-Month, and 24-Month Visits
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections
Official Title  ICMJE An Open-Label, Non-Randomized, Single-Arm, Multi-Center Study to Evaluate Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections in Subjects for Whom Chronic Antibiotic Suppressive Therapy is Indicated
Brief Summary To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.
Detailed Description Prospective, open-label, non-randomized, single-arm trial to evaluate the safety and effectiveness of CEM-102 for chronic antibiotic suppressive therapy of bone or joint infections. Subjects enrolling in this study must have a refractory staphylococcal bone or joint infection that requires suppressive antibiotic therapy (e.g. having an infection that cannot be managed by complete removal of the infected bone or foreign material, a refractory infection not responding to previous treatment, or not being a candidate for long-term intravenous antibiotic therapy).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Refractory Bone or Joint Infections
Intervention  ICMJE Drug: sodium fusidate
Other Names:
  • CEM-102
  • fusidic acid
Study Arms  ICMJE Experimental: CEM-102 (Sodium fusidate)

1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy:

  • 6 months of treatment; or
  • 24 months of treatment (if continued on chronic suppressive therapy)
Intervention: Drug: sodium fusidate
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 21, 2019
Actual Primary Completion Date October 17, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adolescents between 12 and 18 years must weigh >60 kg
  • Bone or joint infection due to an inclusionary pathogen demonstrated from a culture from samples obtained within 6 weeks prior to enrollment
  • Not a candidate, as determined by the Investigator, for suitable alternative therapy
  • After completion of 1-2 weeks of the companion antibiotic, must be a suitable candidate for CEM-102 monotherapy for chronic treatment

Exclusion Criteria:

  • Requires concomitant treatment with OATP1B1 and OATP1B3 substrates, in particular, statins (HMG-CoA reductase inhibitors)
  • Known severe renal impairment, as indicated by estimated CrCl <30 mL/min (by Cockcroft-Gault calculation)
  • Evidence of significant liver disease: ALT >3 × ULN or direct bilirubin >ULN; known cirrhosis with decompensation (i.e. Child-Pugh Class B or C disease)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, 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 NCT02569541
Other Study ID Numbers  ICMJE CE06-302
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arrevus Inc.
Study Sponsor  ICMJE Arrevus Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert Dobbins, MD, PhD Melinta Therapeutics, Inc.
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