Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections (NCT02569541) | Clinical Trial Compass
CompletedPhase 2/3
Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections
United States30 participantsStarted 2015-12
Plain-language summary
To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
* Adolescents between 12 and 18 years must weigh \>60 kg
* Bone or joint infection due to an inclusionary pathogen demonstrated from a culture from samples obtained within 6 weeks prior to enrollment
* Not a candidate, as determined by the Investigator, for suitable alternative therapy
* After completion of 1-2 weeks of the companion antibiotic, must be a suitable candidate for CEM-102 monotherapy for chronic treatment
Exclusion Criteria:
* Requires concomitant treatment with OATP1B1 and OATP1B3 substrates, in particular, statins (HMG-CoA reductase inhibitors)
* Known severe renal impairment, as indicated by estimated CrCl \<30 mL/min (by Cockcroft-Gault calculation)
* Evidence of significant liver disease: ALT \>3 × ULN or direct bilirubin \>ULN; known cirrhosis with decompensation (i.e. Child-Pugh Class B or C disease)