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

NCT01756924 | Terminated Phase 2

• 1 other identifier: CE06-200
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 13

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

Conditions

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

Keywords

prosthetic joint infection; hip arthroplasty; MRSA; knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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.

  3 to 6 months

Study Arms (2)

CEM-102 plus Rifampin

EXPERIMENTAL

Drug: CEM-102; Drug: Rifampin

Standard of Care

ACTIVE COMPARATOR

Drug: IV or Oral standard of care antibiotics

Interventions

CEM-102 DRUG

Also known as: fusidic acid

CEM-102 plus Rifampin

IV or Oral standard of care antibiotics DRUG

Also known as: vancomycin, daptomycin, linezolid, rifampin, ceftriaxone, cefazolin, ceftaroline, nafcillin, oxacillin, ciprofloxacin, levofloxacin, co-trimoxazole

Standard of Care

Rifampin DRUG

CEM-102 plus Rifampin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arrevus Inc.: lead

Study Sites (13)

Unknown Facility

Sarasota, Florida, 34232, United States

Location

Unknown Facility

Tamarac, Florida, 33321, United States

Location

Unknown Facility

Savannah, Georgia, 31419, United States

Location

Unknown Facility

Baltimore, Maryland, 21215, United States

Location

Unknown Facility

Baltimore, Maryland, 21218, United States

Location

Unknown Facility

Boston, Massachusetts, 02215, United States

Location

Unknown Facility

Syracuse, New York, 13507, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19107, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15232, United States

Location

Unknown Facility

Charleston, South Carolina, 29425, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Houston, Texas, 77043, United States

Location

Related Publications (1)

• 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.

  PMID: 27682068 DERIVED

MeSH Terms

Interventions

Fusidic Acid; Vancomycin; Daptomycin; Linezolid; Rifampin; Ceftriaxone; Cefazolin; Ceftaroline; Nafcillin; Oxacillin; Ciprofloxacin; Levofloxacin; Trimethoprim, Sulfamethoxazole Drug Combination

Intervention Hierarchy (Ancestors)

Cholestadienols; Cholestadienes; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Membrane Lipids; Lipids; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Peptides, Cyclic; Macrocyclic Compounds; Lipopeptides; Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Penicillins; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Ofloxacin; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Trimethoprim; Pyrimidines; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 28, 2012
• Study Start: December 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 19, 2019

Record last verified: 2019-04

Locations

US (13)