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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Angelique Boutzoukas, MD, MPH
- 電話番号：919-668-4733
- メール：angelique.boutzoukas@duke.edu
研究場所
-
-
North Carolina
-
Durham、North Carolina、アメリカ、27705
- 募集
- Duke Health Neonatal Intensive Care Unit
-
コンタクト：
- Stefany Olague, MPH
- メール：smalltrials-CRC@duke.edu
-
コンタクト：
- Angelique E Boutzoukas, MD, MPH
- 電話番号：919-668-4733
- メール：angelique.boutzoukas@duke.edu
-
主任研究者：
- Angelique E Boutzoukas, MD, MPH
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total plasma ampicillin concentration
時間枠：data will be collected up to 50 hours from the first dose of ampicillin
|
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
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Serious, unexpected, suspected adverse reactions to ampicillin
時間枠：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
|
|
Adverse events related to study procedures
時間枠：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
時間枠：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
|
|
Antibiotic re-initiation within 7 days of short-course ampicillin
時間枠：Data will be collected until 7 days from short-course ampicillin
|
Data will be collected until 7 days from short-course ampicillin
|
|
Culture-confirmed bacteremia within 7 days of short-course ampicillin
時間枠：Data will be collected until 7 days from short-course ampicillin
|
Data will be collected until 7 days from short-course ampicillin
|
|
Necrotizing enterocolitis within 30 days of short-course ampicillin
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- Pro00119855
- 1K23HD113839 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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