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
- 41
- 试验地点
- 24
- 主要终点
- Percentage of Participants With Any Adverse Events (AEs)
研究概览
简要总结
This is 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 (NP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Days 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
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 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.
研究组 & 干预措施
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia receive intravenous (IV) ceftolozane/tazobactam every 8 hours for 8-14 days.
干预措施: Ceftolozane/Tazobactam (Drug)
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to <12 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
干预措施: Ceftolozane/Tazobactam (Drug)
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Participants 2 to <7 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
干预措施: Ceftolozane/Tazobactam (Drug)
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
干预措施: Ceftolozane/Tazobactam (Drug)
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
干预措施: Ceftolozane/Tazobactam (Drug)
结局指标
主要结局
Percentage of Participants With Any Adverse Events (AEs)
时间窗: Up to 31 days
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants experiencing any AE was reported for each arm.
Percentage of Participants With Any Serious AEs (SAEs)
时间窗: Up to 31 days
An SAE was defined as any untoward medical consequence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other important medical event. The percentage of participants with any SAE was reported for each arm.
Percentage of Participants With Any Drug-related AEs
时间窗: Up to 31 days
A drug-related AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, and considered related to the study intervention. The percentage of participants with any drug related AEs was reported for each arm.
Percentage of Participants With Any Drug-related SAEs
时间窗: Up to 31 days
A drug-related SAE was defined any untoward medical consequence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other important medical event, that is considered related to the study intervention. The percentage of participants with any drug related SAEs was reported for each arm.
Percentage of Participants With AEs Leading to Discontinuation of Study Intervention
时间窗: Up to 14 days
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with AEs leading to discontinuation of study intervention was reported for each arm.
次要结局
- Plasma Concentrations of Ceftolozane(Day 3: 1, between 4-5, and between 7-8 hours post start of infusion)
- Area Under the Concentration-time Curve of an 8-hour Dosing Interval (AUC0-8) of Plasma Ceftolozane(Day 3: 1, between 4-5, and between 7-8 hours post start of infusion)
- Maximum Observed Concentration During a Dosage Interval (Cmax) of Plasma Ceftolozane(Day 3: 1, between 4-5, and between 7-8 hours post start of infusion)
- Elimination Half-life (t1/2) of Plasma Ceftolozane(Day 3: 1, between 4-5, and between 7-8 hours post start of infusion)
- Clearance (CL) of Plasma Ceftolozane(Day 3: 1, between 4-5, and between 7-8 hours post start of infusion)
- Volume of Distribution (Vd) of Plasma Ceftolozane(Day 3: 1, between 4-5, and between 7-8 hours post start of infusion)
- Plasma Concentrations of Tazobactam(Day 3: 1, between 4-5, and between 7-8 hours post start of infusion)
- Area Under the Concentration-time Curve of an 8-hour Dosing Interval (AUC0-8) of Plasma Tazobactam(Day 3: 1, between 4-5, and between 7-8 hours post start of infusion)
- Maximum Observed Concentration During a Dosage Interval (Cmax) of Plasma Tazobactam(Day 3: 1, between 4-5, and between 7-8 hours post start of infusion)
- Elimination Half-life (t1/2) of Plasma Tazobactam(Day 3: 1, between 4-5, and between 7-8 hours post start of infusion)
- Clearance (CL) of Plasma Tazobactam(Day 3: 1, between 4-5, and between 7-8 hours post start of infusion)
- Volume of Distribution (Vd) of Plasma Tazobactam(Day 3: 1, between 4-5, and between 7-8 hours post start of infusion)