A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CEFTAZIDIME AND AVIBACTAM IN NEONATES AND INFANTS FROM BIRTH TO LESS THAN 3 MONTHS OF AGE WITH SUSPECTED OR CONFIRMED INFECTIONS DUE TO GRAM-NEGATIVE PATHOGENS REQUIRING INTRAVENOUS ANTIBIOTIC TREATMENT
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 48
- 试验地点
- 36
- 主要终点
- Plasma Concentrations of Ceftazidime and Avibactam 2 Hours Post-dose: Part A
研究概览
简要总结
This study will assess the pharmacokinetics, safety, and tolerability of single and multiple doses of intravenous ceftazidime-avibactam in hospitalized infants and neonates from 26 weeks gestation to 3 months of age. In Part A of the study all patients will receive a single dose of ceftazidime-avibactam. In Part B all patients will received multiple doses of ceftazidime-avibactam. Efficacy will be assessed in the infants and neonates receiving multiple doses of ceftazidime-avibactam.
详细描述
This is a 2-part, Phase 2a, non-randomized, open-label multicenter, multinational study of intravenous ceftazidime-avibactam in hospitalized neonates and infants with suspected or confirmed bacterial infection. In Part A of the study, patients already receiving intravenous antibacterial therapy with another antibiotic will receive a single intravenous dose of ceftazidime-avibactam followed by observation for 48 hours and a Late Follow-Up assessment 4-5 weeks later. In Part B of the study, patients with suspected or confirmed Gram-negative bacterial infections requiring intravenous antibacterial therapy will receive multiple doses of intravenous ceftazidime-avibactam for up to 14 days. At the discretion of the investigator, patients may also receive other antibiotics if the infection is suspected to include Gram-positive bacteria, multi-drug resistant Gram-negative bacteria, or anaerobic bacteria. At the discretion of the investigator, patients may be switched to oral therapy or outpatient parenteral antimicrobial therapy with an alternative antibiotic after receiving intravenous ceftazidime-avibactam for at least 48 yhours. Clinical outcomes will be assessed at the End of Intravenous (EOIV) treatment with ceftazidime-avibactam, the End-of-Therapy (EOT), the Test-of-Cure (TOC) at 7-14 days after the last study therapy and at a Late Follow-Up (LFU) visit, 28-55 days after the last dose of ceftazidime-avibactam. Safety assessments will occur throughout the study. Ceftazidime-avibactam blood levels will be assessed during the first 12 hours after the single dose of ceftazidime-avibactam in Part A and during 12 hours after at least 3 consecutive doses of ceftazidime-avibactam in Part B.
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
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 88 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Plasma Concentrations of Ceftazidime and Avibactam 2 Hours Post-dose: Part A
时间窗: 2 hours post dose on Day 1
Plasma Concentrations of Ceftazidime and Avibactam 2 Hours and 30 Minutes Post-dose: Part A
时间窗: 2 hours and 30 minutes post dose on Day 1
Plasma Concentrations of Ceftazidime and Avibactam of 7 Hours Post-dose: Part A
时间窗: 7 hours post dose on Day 1
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part B
时间窗: Day 1 up to maximum of Day 49
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying) ; persistent or significant disability/incapacity; congenital anomaly.
Number of Participants Who Discontinued Treatment and Study Due to AEs: Part B
时间窗: Day 1 up to maximum of Day 49
Number of Participants Who Died: Part B
时间窗: Day 1 up to maximum of Day 49
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B
时间窗: Day 1 up to maximum of Day 49
Number of participants in Part B with clinically significant abnormal laboratory parameters that occurred in more than 2 participants from Day 1 up to 35 days after the last dose of CAZ-AVI were reported in this outcome measure. Clinically significant labs were abnormal laboratory results which the investigator reported as being clinically significant. Only parameters with non-zero values are reported.
次要结局
- Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B(EOIV, EOT, TOC, LFU)
- Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B(Up to 34 days)
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs): Part A(Day 1 up to maximum of Day 35)
- Number of Participants Who Died: Part A(Day 1 up to maximum of Day 35)
- Number of Participants Who Discontinued Treatment and Study Due to AEs: Part A(Day 1 up to maximum of Day 35)
- Plasma Concentrations of Ceftazidime and Avibactam 2 Hours, 2 Hours and 30 Minutes, 7 Hours Post Doses on Day 1: Part B(2 hours, 2 hours 30 mins, and 7 hours post dose on Day 1)
- Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B(EOIV, EOT, TOC, LFU)
- Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B(EOIV, EOT, TOC, LFU)
- Number of Participants With Emergent Infections in Micro-ITT Analysis Population: Part B(Day 1 up to maximum of Day 49)
- Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A(Day 1 up to maximum of Day 35)