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 - MK-7625A-036

Merck Sharp & Dohme LLC0 个研究点目标入组 67 人开始时间: 2023年3月9日最近更新: 2024年7月22日

研究概览

暂无简介。

•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

•Has a documented history of any moderate or severe hypersensitivity (or allergic) reaction to any ß-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

发起方