Clinical trial NCT02569541: Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Refractory Bone or Joint Infections
Keywords: fusidic acid
prosthetic joint infections
bone infections
osteomyelitis
Lead sponsor: Arrevus Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-06
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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 \<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)

Primary outcomes:
measure: Clinical Success at 6 Months
timeFrame: 6 months after start of treatment
Secondary outcomes:
measure: Safety and Tolerability
timeFrame: Entire study period - up to 24 months
measure: Clinical Success at 9 Months
timeFrame: 9 months after start of treatment
measure: Clinical Success at 12 Months
timeFrame: 12 months after start of treatment
measure: Clinical Success at 15 Months
timeFrame: 15 months after start of treatment
measure: Clinical Success at 18 Months
timeFrame: 18 months after start of treatment
measure: Clinical Success at 21 Months
timeFrame: 21 months after start of treatment
measure: Clinical Success at 24 Months
timeFrame: 24 months after start of treatment
Other outcomes:
Locations:
city: Fountain Valley
country: United States
state: California
city: San Dimas
country: United States
state: California
city: Sylmar
country: United States
state: California
city: Torrance
country: United States
state: California
city: Tamarac
country: United States
state: Florida
city: Springfield
country: United States
state: Illinois
city: Louisville
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Butte
country: United States
state: Montana
city: Somers Point
country: United States
state: New Jersey
city: Charlotte
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Haverford
country: United States
state: Pennsylvania
city: Malvern
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Melinta Therapeutics, Inc.
name: Robert Dobbins, MD, PhD
role: STUDY_DIRECTOR
References: