Phase 3
N=30
Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections
Refractory Bone or Joint Infections
Bottom Line
View on ClinicalTrials.gov: NCT02569541 ↗Enrolled (actual)
30
Serious AEs
50.0%
Results posted
Jan 2020
Primary outcome: Primary: Clinical Success at 6 Months — 18; 9; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- sodium fusidate (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Arrevus Inc.
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Success at 6 Months |
18; 9; 3 | — |
| SECONDARY Safety and Tolerability |
29; 12; 7; 9; 12; 15 | — |
| SECONDARY Clinical Success at 9 Months |
15; 11; 4 | — |
| SECONDARY Clinical Success at 12 Months |
10; 15; 5 | — |
| SECONDARY Clinical Success at 15 Months |
8; 17; 5 | — |
| SECONDARY Clinical Success at 18 Months |
8; 16; 6 | — |
| SECONDARY Clinical Success at 21 Months |
6; 17; 7 | — |
| SECONDARY Clinical Success at 24 Months |
7; 17; 6 | — |
Summary
To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.
Eligibility Criteria
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 3 × ULN or direct bilirubin >ULN; known cirrhosis with decompensation (i.e. Child-Pugh Class B or C disease)
Data sourced from ClinicalTrials.gov (NCT02569541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.