Conditions: Necrotizing Soft Tissue Infections
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 43
Healthy volunteers: no

Brief summary:
A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care.

Detailed description:
A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care. The primary study hypothesis is that AB-103 can be administered safely to the patients presenting with Necrotizing Soft Tissue Infections.

Secondary endpoints are efficacy by exploratory descriptive analyses of specific efficacy endpoints from three outcome domains to demonstrate treatment benefit of AB103 in comparison to placebo in patients with Necrotizing Soft Tissue Infections. The efficacy domains are:

1. Clinical status domain
2. Pharmacoeconomics domain
3. Systemic and local inflammatory biomarker domain

Arms:
arm 1: None arm 2: None arm 3: Normal saline (0.9% sodium chloride)

Interventions: intervention 1: AB103 intervention 2: Placebo
Intervention descriptions: intervention 1: AB103 0.25 mg/kg or 0.5 mg/kg administered as a single IV infusion intervention 2: Normal saline (0.9% sodium chloride) administered as a single IV infusion

Protocol document: