Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections in Subjects for Whom Chronic Antibiotic Suppressive Therapy is Indicated
Status: | Active, not recruiting |
---|---|
Conditions: | Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 1/5/2019 |
Start Date: | December 2015 |
End Date: | February 2019 |
An Open-Label, Non-Randomized, Single-Arm, Multi-Center Study to Evaluate Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections in Subjects for Whom Chronic Antibiotic Suppressive Therapy is Indicated
To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic
antibiotic for the treatment of bone or joint infections.
antibiotic for the treatment of bone or joint infections.
Prospective, open-label, non-randomized, single-arm trial to evaluate the safety and
effectiveness of CEM-102 for chronic antibiotic suppressive therapy of bone or joint
infections. Subjects enrolling in this study must have a refractory staphylococcal bone or
joint infection that requires suppressive antibiotic therapy (e.g. having an infection that
cannot be managed by complete removal of the infected bone or foreign material, a refractory
infection not responding to previous treatment, or not being a candidate for long-term
intravenous antibiotic therapy).
effectiveness of CEM-102 for chronic antibiotic suppressive therapy of bone or joint
infections. Subjects enrolling in this study must have a refractory staphylococcal bone or
joint infection that requires suppressive antibiotic therapy (e.g. having an infection that
cannot be managed by complete removal of the infected bone or foreign material, a refractory
infection not responding to previous treatment, or not being a candidate for long-term
intravenous antibiotic therapy).
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)
We found this trial at
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