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Optimizing PreTerm Infant Ampicillin Dosing (OPTI-Amp)

3. august 2026 oppdatert 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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • North Carolina
      • Durham, North Carolina, Forente stater, 27705
        • Rekruttering
        • Duke Health Neonatal Intensive Care Unit
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Angelique E Boutzoukas, MD, MPH

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Legemiddel: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total plasma ampicillin concentration
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tidsramme
Serious, unexpected, suspected adverse reactions to ampicillin
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Duke University

Samarbeidspartnere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. juli 2026

Primær fullføring (Antatt)

1. juli 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

21. mai 2026

Først innsendt som oppfylte QC-kriteriene

21. mai 2026

Først lagt ut (Faktiske)

28. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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