Safety and Efficacy of CEM-102 With Rifampin Compared to Standard Therapy in Patients With Prosthetic Joint Infections or Spacer Infection
Information source: Cempra Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prosthetic Joint Infections of Hip; Prosthetic Joint Infections of Knee; Infected Spacers
Intervention: CEM-102 (Drug); IV or Oral standard of care antibiotics (Drug); Rifampin (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Cempra Pharmaceuticals
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
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bacterial eradication of joint infection
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 (FucidinĀ®), 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
Locations and Contacts
Sarasota, Florida 34232, United States
Tamarac, Florida 33321, United States
Savannah, Georgia 31419, United States
Baltimore, Maryland 21215, United States
Baltimore, Maryland 21218, United States
Boston, Massachusetts 02215, United States
Syracuse, New York 13507, United States
Durham, North Carolina 27710, United States
Philadelphia, Pennsylvania 19107, United States
Pittsburgh, Pennsylvania 15232, United States
Charleston, South Carolina 29425, United States
Houston, Texas 77030, United States
Houston, Texas 77043, United States
Additional Information
Starting date: December 2012
Last updated: November 18, 2014
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