Optimizing PreTerm Infant Ampicillin Dosing (OPTI-Amp)
An Open-label, Pharmacokinetic and Safety Trial Optimizing PreTerm Infant Ampicillin Dosing
The goal of this clinical trial is to learn if preterm infants who are prescribed antibiotics shortly after birth can safety receive a shorter course of antibiotics (24 to 36 hours instead of 48 hours). The main questions it aims to answer are:
- Does short-course ampicillin provide high enough levels of ampicillin at 48 hours?
- Is short-course ampicillin safe for preterm infants to receive?
Preterm infants who are being prescribed ampicillin by their doctor and enroll in the study will stop ampicillin after a shorter than typical course, and researchers will collect blood samples to measure their ampicillin levels and follow them clinically to see how they do after receiving short-course ampicillin.
Participants will:
- stop ampicillin earlier than 48 hours (between 24 to 36 hours, depending on how premature they are and the dosing of ampicillin their doctor has prescribed)
- have one or more blood samples collected, including one around 48 hours from when they started ampicillin
- have their data collected until 30 days after they receive short-course ampicillin, or until hospital discharge, whichever is sooner
研究概览
地位
详细说明
OPTI-Amp is a prospective, open-label, non-randomized pharmacokinetic and safety trial of short-course ampicillin administered to preterm neonates in the Neonatal Intensive Care Unit (NICU) at Duke.
The objectives of the study are to 1) evaluate whether short-course ampicillin provides therapeutic exposures for 48 hours from ampicillin initiation for preterm neonates undergoing evaluation of early onset sepsis (EOS) and 2) evaluate the safety of short-course ampicillin compared to standard empiric ampicillin. The prescribing of drugs to infants will not be part of this protocol.
Approximately 60 neonates ≤34 weeks gestational age and <7 days postnatal age at the time of screening, who are receiving empiric ampicillin prescribed per standard of care (SOC) by their treating provider will be enrolled in the study. Participants will be in the study up to 30 days or hospital discharge, whichever is sooner. Enrolled infants who receive short-course ampicillin will have a pharmacokinetic sample collected at 48 (+/-2) hours from the time that ampicillin was initiated. Additional opportunistic pharmacokinetic (PK) samples can be collected between enrollment and 72 hours from ampicillin initiation if the patient is receiving other SOC labs; however, these are not required. Demographic information, clinical data, and biospecimen information (including date and time of sample collection) will also be collected for enrolled participants.
All enrolled infants will be in the safety population. Those with at least one PK sample will be included in the PK population. In addition to the risks of blood drawing and loss of confidentiality, there may be a risk of under treatment of EOS if clinical cultures result positive after ampicillin discontinuation and therapeutic exposure is not maintained between 24 or 36 hours until 48 hours. Participants that fall under the latter situation will either not be enrolled in the study or will be withdrawn as determined by the study PI.
研究类型
注册 (估计的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习联系方式
- 姓名：Angelique Boutzoukas, MD, MPH
- 电话号码：919-668-4733
- 邮箱：angelique.boutzoukas@duke.edu
学习地点
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North Carolina
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Durham、North Carolina、美国、27705
- 招聘中
- Duke Health Neonatal Intensive Care Unit
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接触：
- Stefany Olague, MPH
- 邮箱：smalltrials-CRC@duke.edu
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接触：
- Angelique E Boutzoukas, MD, MPH
- 电话号码：919-668-4733
- 邮箱：angelique.boutzoukas@duke.edu
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首席研究员：
- Angelique E Boutzoukas, MD, MPH
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-
参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria:
- Documented informed consent from parent/guardian
- Infants admitted to the Duke Neonatal Intensive Care Unit (NICU)
- less than or equal to 34 completed weeks gestational age (GA) at birth and < 7 days of life at time of screening
- Prescribed ampicillin by provider per standard of care for evaluation of early onset sepsis
Exclusion Criteria:
- Infant on extracorporeal support (e.g., ECMO)
- Positive blood culture or other confirmed infection
- At time of consent, infants with GA <28 completed weeks who have received more than 24 hours of empiric ampicillin OR infants with GA 28 to 34 completed weeks who have received > 32 to 36 hours of ampicillin, depending on dosing regimen
- Has major congenital abnormalities where survival to 30 days of life is not expected
- Receives a course of ampicillin that is longer (i.e., more doses) than the short-course defined regimen for their GA
- Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Short-course Ampicillin
Infants enrolled in the trial receive short-course empiric ampicillin (24 to 36 hours, depending on gestational age and prescribed dosing regimen), rather than a standard (48 hour) empiric ampicillin course
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preterm infants receive less than 48 hours of prescribed ampicillin (i.e., a "short-course" ampicillin regimen) to provide the desired 48 hours of therapeutic exposures
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total plasma ampicillin concentration
大体时间：data will be collected up to 50 hours from the first dose of ampicillin
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Total plasma ampicillin concentration at 48(+/-) 2 hours after ampicillin initiation, following a single gestational age defined short-course with no further ampicillin administration.
Target attainment defined as total ampicillin concentration of ≥1 µg/mL.
The short-course regimen is considered successful if target attainment is achieved in ≥90% of the overall study population.
|
data will be collected up to 50 hours from the first dose of ampicillin
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Serious, unexpected, suspected adverse reactions to ampicillin
大体时间：Data will be collected until 30 days from short-course ampicillin, or until hospital discharge
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Data will be collected until 30 days from short-course ampicillin, or until hospital discharge
|
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Adverse events related to study procedures
大体时间：Data will be collected until 30 days from short-course ampicillin, or until hospital discharge
|
Data will be collected until 30 days from short-course ampicillin, or until hospital discharge
|
|
All-cause mortality at 30 days
大体时间：Data will be collected until 30 days from short-course ampicillin, or until hospital discharge
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Data will be collected until 30 days from short-course ampicillin, or until hospital discharge
|
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Antibiotic re-initiation within 7 days of short-course ampicillin
大体时间：Data will be collected until 7 days from short-course ampicillin
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Data will be collected until 7 days from short-course ampicillin
|
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Culture-confirmed bacteremia within 7 days of short-course ampicillin
大体时间：Data will be collected until 7 days from short-course ampicillin
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Data will be collected until 7 days from short-course ampicillin
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Necrotizing enterocolitis within 30 days of short-course ampicillin
大体时间：Data will be collected until 30 days from short-course ampicillin, or until hospital discharge
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Data will be collected until 30 days from short-course ampicillin, or until hospital discharge
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Pro00119855
- 1K23HD113839 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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