Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections

Completed · Phase 2/Phase 3

Conditions studied: Refractory Bone or Joint Infections

In brief

To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.

Key facts

Study ID

NCT02569541

Run by

Arrevus Inc.

People needed

30

Starts

2015-12-01

Expected to finish

2019-02-21

Last updated by the study team

2020-01-30

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Fountain Valley, California, United States
• Study site — San Dimas, California, United States
• Study site — Sylmar, California, United States
• Study site — Torrance, California, United States
• Study site — Tamarac, Florida, United States
• Study site — Springfield, Illinois, United States
• Study site — Louisville, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Butte, Montana, United States
• Study site — Somers Point, New Jersey, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Haverford, Pennsylvania, United States
• Study site — Malvern, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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