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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-07-31

Brief Summary

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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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CEM-102 plus Rifampin

Group Type EXPERIMENTAL

CEM-102

Intervention Type DRUG

Rifampin

Intervention Type DRUG

Standard of Care

Group Type ACTIVE_COMPARATOR

IV or Oral standard of care antibiotics

Intervention Type DRUG

Interventions

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CEM-102

Intervention Type DRUG

IV or Oral standard of care antibiotics

Intervention Type DRUG

Rifampin

Intervention Type DRUG

Other Intervention Names

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fusidic acid vancomycin daptomycin linezolid rifampin ceftriaxone cefazolin ceftaroline nafcillin oxacillin ciprofloxacin levofloxacin co-trimoxazole

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No