C3601010: A Phase 2A, 2-Part, Open-Label, Non-Randomized, Multicenter, Single and Multiple Dose Trial to Evaluate Pharmacokinetics, Safety and Tolerability of Aztreonam and Avibactam ± Metronidazole in Neonates and Infants From Birth to Less Than 9 Months of Age With Suspected or Confirmed Infections Due to Gram-Negative Pathogens Requiring Intravenous Antibiotic Treatment

Sepsis, Suspected or Confirmed Infections Due to Gram-Negative Pathogens Requiring Intravenous Antibiotic Treatment, Complicated Urinary Tract Infection, Blood Stream Infection, Hospital-acquired pneumonia or ventilator-associated pneumonia, Complicated Intra-abdominal Infection

PK parameters including clearance (CL), maximum plasma concentration (Cmax), area under the plasma concentration time curve (AUC) and half-life (t1/2), Plasma concentrations of ATM and AVI on Day 1 and at steady state (Day 2 or later), Adverse events (AEs) and Serious Adverse Events (SAEs), Adverse events leading to discontinuation and adverse events resulting in death, Assessments of liver and renal functions tests at baseline, while on treatment and after end of treatment

Clinical outcomes at End of Intravenous Treatment (EOIV), End of Treatment (EOT), and Test of Cure (TOC). (Pat B only), Per-pathogen microbiological response at EOIV/EOT, and TOC., Per-participant microbiological response at TOC, Emergent infection

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