Nosocomial infection, Pneumonia
Conditions
Brief summary
Percentage of participants with any adverse events (AEs), Percentage of participants with any serious AEs (SAEs), Percentage of participants with any drug-related AEs, Percentage of participants with any drug-related SAEs, Percentage of participants with AEs leading to discontinuation of study intervention
Detailed description
Plasma concentrations of ceftolozane, Plasma concentrations of tazobactam, Steady state plasma area under the concentration-time curve of an 8-hour dosing interval (AUC0-8) of plasma ceftolozane, Steady state plasma area under the concentration-time curve of an 8-hour dosing interval (AUC0-8) of plasma tazobactam, Maximum observed concentration during a dosage interval (Cmax) of plasma ceftolozane, Maximum observed concentration during a dosage interval (Cmax) of plasma tazobactam, Elimination half-life (t1/2) of plasma ceftolozane, Elimination half-life (t1/2) of plasma tazobactam, Volume of distribution (Vd) of plasma ceftolozane, Volume of distribution (Vd) of plasma tazobactam, Clearance (CL) of plasma ceftolozane, Clearance (CL) of plasma tazobactam
Interventions
Sponsors
Merck Sharp & Dohme LLC
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations of ceftolozane, Plasma concentrations of tazobactam, Steady state plasma area under the concentration-time curve of an 8-hour dosing interval (AUC0-8) of plasma ceftolozane, Steady state plasma area under the concentration-time curve of an 8-hour dosing interval (AUC0-8) of plasma tazobactam, Maximum observed concentration during a dosage interval (Cmax) of plasma ceftolozane, Maximum observed concentration during a dosage interval (Cmax) of plasma tazobactam, Elimination half-life (t1/2) of plasma ceftolozane, Elimination half-life (t1/2) of plasma tazobactam, Volume of distribution (Vd) of plasma ceftolozane, Volume of distribution (Vd) of plasma tazobactam, Clearance (CL) of plasma ceftolozane, Clearance (CL) of plasma tazobactam | — |
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with any adverse events (AEs), Percentage of participants with any serious AEs (SAEs), Percentage of participants with any drug-related AEs, Percentage of participants with any drug-related SAEs, Percentage of participants with AEs leading to discontinuation of study intervention | — |
Countries
Estonia, Greece, Spain
Outcome results
None listed