Acute Bacterial Skin and Skin Structure Infections
Conditions
Keywords
fusidic acid, skin infection
Brief summary
Phase 3, randomized, double-blind, multi-center efficacy and safety study to evaluate an oral CEM-102 loading dose regimen compared to oral linezolid in the treatment of subjects with ABSSSI
Detailed description
The primary objective is to demonstrate the non-inferiority of oral CEM-102 (loading dose regimen of 1500 mg every 12 hours for 2 doses, followed by 600 mg every 12 hours thereafter) compared to oral linezolid (600 mg every 12 hours), each administered for 10 days, for Early Clinical Response (ECR) in the intent to treat (ITT) analysis set in subjects with acute bacterial skin and skin structure infections (ABSSSI). Subjects with an ABSSSI caused by suspected or documented Gram-positive pathogen(s) at baseline will be randomized 1:1 to study treatment
Interventions
DRUGsodium fusidate
DRUGlinezolid
Sponsors
Arrevus Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adolescents between 12 to 18 years old must weigh \>60 kg * Patients diagnosed with ABSSSI with at least one systemic sign of infection * Diagnosed with cellulitis, major cutaneous abscess, or wound infections (traumatic or surgical) * Surface redness, edema or induration must be of a minimum surface area of 75 cm2, or extending ≥5 cm from the peripheral margin of the abscess * Suspected or documented ABSSSI caused by a Gram-positive pathogen
Exclusion criteria
* Involving a chronic diabetic foot infection (diabetic foot ulcer) * Involving burns * Involving an anatomical location (e.g. perirectal area) where the incidence of Gram-negative and/or anaerobic pathogen involvement is likely * Documented bacteremia associated with the current ABSSSI * Known severe renal impairment, as indicated by estimated CrCl \<30 mL/min (by Cockcroft-Gault calculation) * Evidence of significant liver disease: ALT \>3x ULN, or direct bilirubin \>ULN; known cirrhosis with decompensation (i.e. Child-Pugh Class B or C disease)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with a response for Early Clinical Response | 48 to 72 hours after starting treatment | Proportion of subjects with a response for Early Clinical Response (ECR), defined as alive and achieved ≥ 20% reduction from baseline in the lesion size at 48-72 hours after start of study drug, without receipt of additional non-study antibiotic therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with clinical success at Post-treatment Evaluation | 7 to 14 days after end of treatment | Proportion of subjects with clinical success at PTE, in the ITT and clinically evaluable (CE) analysis sets. |
| Incidence of adverse events [Safety and tolerability], Clinical Laboratory Evaluations | Up to 24 months | Incidence of adverse events, vital sign changes, physical exam changes, and clinical laboratory evaluations will be presented by study arm |
Countries
Puerto Rico, United States
Outcome results
None listed