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

This study is currently recruiting participants.
Verified May 2013 by Cempra Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Cempra Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01756924
First received: December 18, 2012
Last updated: May 10, 2013
Last verified: May 2013
History of Changes
  Purpose

To determine if oral antibiotic treatment with CEM-102 and Rifampin is as effective and safe as the standard of care intravenous antibiotic therapy for the treatment of infected hip and knee joints after joint replacement surgery.


Condition Intervention Phase
Prosthetic Joint Infections of Hip or Knee Joints
 Drug: CEM-102 plus Rifampin
Drug: IV vancomycin, nafcillin, oxacillin, ceftriaxone or cefazolin
 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:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by Cempra Pharmaceuticals:

Primary Outcome Measures:
  • Bacterial eradication of joint infection [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CEM-102 plus Rifampin Drug: CEM-102 plus Rifampin
Active Comparator: IV vancomycin, nafcillin, oxacillin, ceftriaxone or cefazolin Drug: IV vancomycin, nafcillin, oxacillin, ceftriaxone or cefazolin

  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
  • 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 gram-positive bacterial pathogens (confirmed by intraoperative culture).

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
  • Known HIV or Hepatitis C infection
  • Seizure disorder, requiring anti-convulsants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756924

Contacts
Contact: David Taylor 919-576-2305 dtaylor@cempra.com

Locations
United States, Florida
Recruiting
Sarasota, Florida, United States, 34232
Recruiting
Tamarac, Florida, United States, 33321
United States, Michigan
Recruiting
Detroit, Michigan, United States, 48202
United States, North Carolina
Recruiting
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Recruiting
Houston, Texas, United States, 77030
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: May 10, 2013
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:
Arthritis, Infectious
Infection
Arthritis
Joint Diseases
Musculoskeletal Diseases
Cefazolin
Ceftriaxone
Nafcillin
Oxacillin
Rifampin
Vancomycin
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antitubercular
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013