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Optimizing PreTerm Infant Ampicillin Dosing (OPTI-Amp)

3 augusti 2026 uppdaterad av: Duke University

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

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27705
        • Rekrytering
        • Duke Health Neonatal Intensive Care Unit
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Angelique E Boutzoukas, MD, MPH

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Läkemedel: Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis
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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Total plasma ampicillin concentration
Tidsram: 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

Sekundära resultatmått

Resultatmått
Tidsram
Serious, unexpected, suspected adverse reactions to ampicillin
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Duke University

Samarbetspartners

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

28 juli 2026

Primärt slutförande (Beräknad)

1 juli 2027

Avslutad studie (Beräknad)

31 december 2027

Studieregistreringsdatum

Först inskickad

21 maj 2026

Först inskickad som uppfyllde QC-kriterierna

21 maj 2026

Första postat (Faktisk)

28 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • Pro00119855
  • 1K23HD113839 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

All IPD collected for study purposes will be shared to the NICHD DASH data repository.

Tidsram för IPD-delning

The IPD and supporting information will be available once data analysis is complete and will be available per NICHD DASH repository timelines.

Kriterier för IPD Sharing Access

Qualified researchers and scientists from academic, non-profit, and for-profit institutions can access data sent to NICHD DASH repository for secondary analysis. Access is controlled, requiring approval from the DASH Data Access Committee (DAC) after the investigator submits a research proposal, a data use agreement (DUA), and a study-specific Data Management and Sharing Plan.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • ICF

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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