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

April 15, 2019 updated by: Arrevus Inc.
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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34232
      • Tamarac, Florida, United States, 33321
    • Georgia
      • Savannah, Georgia, United States, 31419
    • Maryland
      • Baltimore, Maryland, United States, 21215
      • Baltimore, Maryland, United States, 21218
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • New York
      • Syracuse, New York, United States, 13507
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
      • Pittsburgh, Pennsylvania, United States, 15232
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Texas
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77043

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care
Drug: IV or Oral standard of care antibiotics
Other Names:
  • co-trimoxazole
  • levofloxacin
  • rifampin
  • ciprofloxacin
  • nafcillin
  • vancomycin
  • ceftriaxone
  • oxacillin
  • cefazolin
  • linezolid
  • daptomycin
  • ceftaroline
Experimental: CEM-102 plus Rifampin
Drug: Rifampin
Drug: CEM-102
Other Names:
  • fusidic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacterial eradication of joint infection
Time Frame: 3 to 6 months
Clinical success is defined as the absence of persistent infection in a patient who did not receive alternative antibiotic therapy targeting the infection.
3 to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arrevus Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

December 18, 2012

First Submitted That Met QC Criteria

December 20, 2012

First Posted (Estimate)

December 28, 2012

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE06-200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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