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 a blood sample collected 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
Przegląd badań
Status
Warunki
Szczegółowy opis
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 the final ampicillin dose (time of 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.
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 2
- Faza 1
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Angelique Boutzoukas, MD, MPH
- Numer telefonu: 919-668-4733
- E-mail: angelique.boutzoukas@duke.edu
Lokalizacje studiów
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North Carolina
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Durham, North Carolina, Stany Zjednoczone, 27705
- Duke Health Neonatal Intensive Care Unit
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Kontakt:
- Angelique Boutzoukas, MD, MPH
- Numer telefonu: 919-668-4733
- E-mail: angelique.boutzoukas@duke.edu
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Kontakt:
- Stefany Olague, MPH
- E-mail: smalltrials-CRC@duke.edu
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Główny śledczy:
- Angelique Boutzoukas, MD, MPH
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
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
- Failure to obtain consent from parent/guardian
- 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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Free plasma ampicillin concentration
Ramy czasowe: data will be collected up to 50 hours from the first dose of ampicillin
|
Free 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 free 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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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
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Serious, unexpected, suspected adverse reactions to ampicillin
Ramy czasowe: 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
|
|
Adverse events related to study procedures
Ramy czasowe: 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
|
|
All-cause mortality at 30 days
Ramy czasowe: 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
Ramy czasowe: Data will be collected until 7 days from short-course ampicillin
|
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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- Pro00119855
- 1K23HD113839 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- ICF
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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