2022-501110-56-00已完成1 期
A Phase 1, open-label, non-comparative, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of ceftolozane/tazobactam (MK-7625A) in pediatric participants with nosocomial pneumonia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Percentage of participants with any adverse events (AEs)
研究概览
简要总结
To evaluate the safety and tolerability of ceftolozane/tazobactam for all participants
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Is hospitalized and anticipated to receive a minimum of 8 days of concomitant standard-of-care [SOC] antibiotic therapy for proven or suspected nosocomial pneumonia (NP)
- •If male, is abstinent from heterosexual intercourse, or agrees to use contraception during the intervention period and for ≥30 days after the last dose of study intervention
- •If female, is not pregnant or breastfeeding, or is not a woman of childbearing potential (WOCBP), or is a WOCBP using acceptable contraception, is a WOCBP with negative urine or serum pregnancy test within 48 hours of the first dose of study intervention, or is abstinent from heterosexual intercourse
排除标准
- •Has a documented history of any moderate or severe hypersensitivity (or allergic) reaction to any β-lactam antibacterial
- •Participants 3 months to <18 years of age: has moderate to severe impairment of renal function, defined as an estimated creatinine clearance (CrCL) <50 mL/min/1.73 m2 based on the revised Schwartz equation or requirement for peritoneal dialysis, hemodialysis, or hemofiltration
- •Participants <3 months of age: has CrCL <20 mL/min/1.73 m2 based on the revised Schwartz equation or requirement for peritoneal dialysis, hemodialysis, or hemofiltration
- •Is receiving or is anticipated to receive piperacillin/tazobactam while receiving ceftolozane/tazobactam or has received piperacillin/tazobactam within 24 hours prior to the first dose of ceftolozane/tazobactam
- •Has participated in any clinical study of a therapeutic investigational product within 30 days prior to the first dose of ceftolozane/tazobactam
- •Has previous participation in any study of ceftolozane or ceftolozane/tazobactam
- •Has any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of study data
- •Has any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure or septic shock
- •Has active immunosuppression
结局指标
主要结局
Percentage of participants with any adverse events (AEs)
Percentage of participants with any adverse events (AEs)
Percentage of participants with any serious AEs (SAEs)
Percentage of participants with any serious AEs (SAEs)
Percentage of participants with any drug-related AEs
Percentage of participants with any drug-related AEs
Percentage of participants with any drug-related SAEs
Percentage of participants with any drug-related SAEs
Percentage of participants with AEs leading to discontinuation of study intervention
Percentage of participants with AEs leading to discontinuation of study intervention
次要结局
- 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
研究者
Stephen Richard Holden
Scientific
Merck Sharp & Dohme LLC
研究点 (4)
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