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

Arrevus

Status and phase: Terminated; Phase 2

Conditions: Prosthetic Joint Infections of Hip; Infected Spacers; Prosthetic Joint Infections of Knee

Treatments: Drug: IV or Oral standard of care antibiotics; Drug: Rifampin; Drug: CEM-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT01756924

CE06-200

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

CEM-102 plus Rifampin

Experimental group

Treatment:

Drug: Rifampin

Drug: CEM-102

Standard of Care

Active Comparator group

Treatment:

Drug: IV or Oral standard of care antibiotics