Infected Spacers, Prosthetic Joint Infections of Hip, Prosthetic Joint Infections of Knee
Conditions
Keywords
prosthetic joint infection, hip arthroplasty, MRSA, knee arthroplasty
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
Interventions
Sponsors
Arrevus Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial eradication of joint infection | 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. |
Countries
United States
Outcome results
None listed