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This study has been terminated; alternative study designs are being considered. Fusidic acid remains available under an Expanded Access Protocol.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CEM-102 plus Rifampin | Experimental |
| |
| Standard of Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEM-102 | Drug |
|
| |
| IV or Oral standard of care antibiotics |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarasota | Florida | 34232 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27682068 | Derived | 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. |
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| Drug |
|
|
| Rifampin | Drug |
|
| Tamarac |
| Florida |
| 33321 |
| United States |
| Savannah | Georgia | 31419 | United States |
| Baltimore | Maryland | 21215 | United States |
| Baltimore | Maryland | 21218 | United States |
| Boston | Massachusetts | 02215 | United States |
| Syracuse | New York | 13507 | United States |
| Durham | North Carolina | 27710 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Pittsburgh | Pennsylvania | 15232 | United States |
| Charleston | South Carolina | 29425 | United States |
| Houston | Texas | 77030 | United States |
| Houston | Texas | 77043 | United States |
| ID | Term |
|---|---|
| D005672 | Fusidic Acid |
| D014640 | Vancomycin |
| D017576 | Daptomycin |
| D000069349 | Linezolid |
| D012293 | Rifampin |
| D002443 | Ceftriaxone |
| D002437 | Cefazolin |
| D000097583 | Ceftaroline |
| D009254 | Nafcillin |
| D010068 | Oxacillin |
| D002939 | Ciprofloxacin |
| D064704 | Levofloxacin |
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D002775 | Cholestadienols |
| D002774 | Cholestadienes |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D055666 | Lipopeptides |
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D010406 | Penicillins |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D015242 | Ofloxacin |
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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