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This refers to a specific therapeutic regimen evaluated in a Phase 4 clinical trial (NCT01800396) conducted by the Centre Hospitalier Universitaire de Nîmes. The study investigated the pharmacokinetics and target attainment of high-dose aminoglycoside antibiotics—specifically 30 mg/kg of amikacin or 8 mg/kg of gentamicin—in critically ill patients with severe sepsis or septic shock. Aminoglycosides are small molecule antibiotics that exert their bactericidal effect by binding to the 30S ribosomal subunit, thereby inhibiting bacterial protein synthesis and causing mistranslation. The trial was designed to address the common issue of underdosing in ICU patients due to increased volume of distribution and altered clearance, finding that higher doses were necessary to achieve optimal peak serum concentrations (Cmax) for efficacy against Gram-negative pathogens.
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