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
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 2 단계
- 1단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Angelique Boutzoukas, MD, MPH
- 전화번호: 919-668-4733
- 이메일: angelique.boutzoukas@duke.edu
연구 장소
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North Carolina
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Durham, North Carolina, 미국, 27705
- 모병
- Duke Health Neonatal Intensive Care Unit
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연락하다:
- Stefany Olague, MPH
- 이메일: smalltrials-CRC@duke.edu
-
연락하다:
- Angelique E Boutzoukas, MD, MPH
- 전화번호: 919-668-4733
- 이메일: angelique.boutzoukas@duke.edu
-
수석 연구원:
- Angelique E Boutzoukas, MD, MPH
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total plasma ampicillin concentration
기간: 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.
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data will be collected up to 50 hours from the first dose of ampicillin
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2차 결과 측정
2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Serious, unexpected, suspected adverse reactions to ampicillin
기간: 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
기간: 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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All-cause mortality at 30 days
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
협력자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- Pro00119855
- 1K23HD113839 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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