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

NCT01756924 — Phase 2, Terminated, 14 participants, Arrevus Inc.
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT01756924
StatusTerminated - This study has been terminated; alternative study designs are being considered. Fusidic acid remains available under an Expanded Access Protocol.
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment14 (Actual)
SponsorArrevus Inc. (Industry)
ConditionsProsthetic Joint Infections of Hip, Prosthetic Joint Infections of Knee, Infected Spacers
InterventionsCEM-102, IV or Oral standard of care antibiotics, Rifampin (Drug)
Datesstart 2012-12-01, primary completion 2014-07-01, completion 2014-07-01, first posted 2012-12-28, last updated 2019-04-19
Locations13 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Prosthetic Joint Infections of Hip All trials for Prosthetic Joint Infections of Knee All trials of CEM-102 All trials of IV or Oral standard of care antibiotics

-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

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+Arms and interventions

ArmTypeInterventionsDescription
CEM-102 plus RifampinExperimentalDrug: CEM-102; Drug: Rifampin
Standard of CareActive comparatorDrug: IV or Oral standard of care antibiotics
  • CEM-102 (Drug), also known as fusidic acid
  • IV or Oral standard of care antibiotics (Drug), also known as vancomycin, daptomycin, linezolid, rifampin, ceftriaxone, cefazolin, ceftaroline, nafcillin, oxacillin, ciprofloxacin, levofloxacin, co-trimoxazole
  • Rifampin (Drug)

+Outcome measures

Primary outcomes

  • Bacterial eradication of joint infection [3 to 6 months]: Clinical success is defined as the absence of persistent infection in a patient who did not receive alternative antibiotic therapy targeting the infection.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (13)

FacilityCityCountryStatus
Sarasota, FloridaUnited States
Tamarac, FloridaUnited States
Savannah, GeorgiaUnited States
Baltimore, MarylandUnited States
Baltimore, MarylandUnited States
Boston, MassachusettsUnited States
Syracuse, New YorkUnited States
Durham, North CarolinaUnited States
Philadelphia, PennsylvaniaUnited States
Pittsburgh, PennsylvaniaUnited States
Charleston, South CarolinaUnited States
Houston, TexasUnited States
Houston, TexasUnited States

+Publications

  • Results publication: 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