drugset / Trial / NCT01756924

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

Phase 2 Terminated 14 enrolled Arrevus Inc.

RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start: 2012-12
Primary completion: 2014-07
Completion: 2014-07

Outcome

Outcome not reported

Stopped: “This study has been terminated; alternative study designs are being considered. Fusidic acid remains available under an Expanded Access Protocol.”

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fusidic Acid	Unknown	—	Oral
Subject	Rifampicin	Small molecule	—	Oral
Comparator	Cefazolin	Small molecule	—	Intravenous
Comparator	Ceftaroline	Other / unclassified	—	Intravenous
Comparator	Ceftriaxone	Other / unclassified	—	Intravenous
Comparator	Ciprofloxacin	Small molecule	—	Intravenous
Comparator	Cotrimoxazole	Small molecule	—	Intravenous
Comparator	Daptomycin	Other / unclassified	—	Intravenous
Comparator	Levofloxacin	Small molecule	—	Intravenous
Comparator	Linezolid	Other / unclassified	—	Intravenous
Subject	Rifampicin	Small molecule	—	Intravenous
Comparator	Vancomycin	Other / unclassified	—	Intravenous
Comparator	nafcillin	Small molecule	—	Intravenous
Comparator	oxacillin	Small molecule	—	Intravenous