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

This study has been terminated.
(This study has been terminated; alternative study designs are being considered. Fusidic acid remains available under an Expanded Access Protocol.)
Sponsor:
Information provided by (Responsible Party):
Cempra Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01756924
First received: December 18, 2012
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Prosthetic Joint Infections of Hip or Knee; Infected Spacers
Drug: CEM-102 plus Rifampin
Drug: IV or Oral standard of care antibiotics
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Cempra Pharmaceuticals:

Primary Outcome Measures:
  • Bacterial eradication of joint infection [ Time Frame: 3 to 6 months ] [ Designated as safety issue: No ]
    Clinical success is defined as the absence of persistent infection in a patient who did not receive alternative antibiotic therapy targeting the infection.


Enrollment: 14
Study Start Date: December 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CEM-102 plus Rifampin Drug: CEM-102 plus Rifampin
Active Comparator: Standard of Care Drug: IV or Oral standard of care antibiotics

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756924

Locations
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, 21218
Baltimore, Maryland, United States, 21215
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
Cempra Pharmaceuticals
  More Information

No publications provided

Responsible Party: Cempra Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01756924     History of Changes
Other Study ID Numbers: CE06-200
Study First Received: December 18, 2012
Last Updated: June 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cempra Pharmaceuticals:
prosthetic joint infection
hip arthroplasty
MRSA
knee arthroplasty

Additional relevant MeSH terms:
Infection
Communicable Diseases
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014