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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Arrevus Inc.
- Enrollment
- 30
- Primary Endpoint
- Clinical Success at 6 Months
Study Overview
Brief Summary
To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
CEM-102 (Sodium fusidate)
1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy:
- 6 months of treatment; or
- 24 months of treatment (if continued on chronic suppressive therapy)
Intervention: sodium fusidate (Drug)
Outcomes
Primary Outcomes
Clinical Success at 6 Months
Time Frame: 6 months after start of treatment
Number of participants in the intent to treat (ITT) analysis set who meet all the criteria for clinical success at the 6-Month Visit. Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia
Secondary Outcomes
- Safety and Tolerability(Entire study period - up to 24 months)
- Clinical Success at 9 Months(9 months after start of treatment)
- Clinical Success at 12 Months(12 months after start of treatment)
- Clinical Success at 15 Months(15 months after start of treatment)
- Clinical Success at 18 Months(18 months after start of treatment)
- Clinical Success at 21 Months(21 months after start of treatment)
- Clinical Success at 24 Months(24 months after start of treatment)