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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

Primary Purpose

Prosthetic Joint Infections of Hip, Prosthetic Joint Infections of Knee, Infected Spacers

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CEM-102
IV or Oral standard of care antibiotics
Rifampin
Sponsored by
Arrevus Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prosthetic Joint Infections of Hip focused on measuring prosthetic joint infection, hip arthroplasty, MRSA, knee arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CEM-102 plus Rifampin

Standard of Care

Arm Description

Outcomes

Primary Outcome Measures

Bacterial eradication of joint infection
Clinical success is defined as the absence of persistent infection in a patient who did not receive alternative antibiotic therapy targeting the infection.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2012
Last Updated
April 15, 2019
Sponsor
Arrevus Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01756924
Brief Title
Safety and Efficacy of CEM-102 With Rifampin Compared to Standard Therapy in Patients With Prosthetic Joint Infections or Spacer Infection
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
This study has been terminated; alternative study designs are being considered. Fusidic acid remains available under an Expanded Access Protocol.
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arrevus Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthetic Joint Infections of Hip, Prosthetic Joint Infections of Knee, Infected Spacers
Keywords
prosthetic joint infection, hip arthroplasty, MRSA, knee arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CEM-102 plus Rifampin
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
CEM-102
Other Intervention Name(s)
fusidic acid
Intervention Type
Drug
Intervention Name(s)
IV or Oral standard of care antibiotics
Other Intervention Name(s)
vancomycin, daptomycin, linezolid, rifampin, ceftriaxone, cefazolin, ceftaroline, nafcillin, oxacillin, ciprofloxacin, levofloxacin, co-trimoxazole
Intervention Type
Drug
Intervention Name(s)
Rifampin
Primary Outcome Measure Information:
Title
Bacterial eradication of joint infection
Description
Clinical success is defined as the absence of persistent infection in a patient who did not receive alternative antibiotic therapy targeting the infection.
Time Frame
3 to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31419
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13507
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27682068
Citation
Pushkin R, Iglesias-Ussel MD, Keedy K, MacLauchlin C, Mould DR, Berkowitz R, Kreuzer S, Darouiche R, Oldach D, Fernandes P. A Randomized Study Evaluating Oral Fusidic Acid (CEM-102) in Combination With Oral Rifampin Compared With Standard-of-Care Antibiotics for Treatment of Prosthetic Joint Infections: A Newly Identified Drug-Drug Interaction. Clin Infect Dis. 2016 Dec 15;63(12):1599-1604. doi: 10.1093/cid/ciw665. Epub 2016 Sep 28.
Results Reference
derived

Learn more about this trial

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

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