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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

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


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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

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