Shorter ampicillin course for preterm infants with early onset sepsis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

OPTI-Amp is a prospective, open-label study in preterm neonates in the Duke NICU to see if a shorter ampicillin course (24–36 hours) can achieve adequate drug exposure at 48 hours and maintain safety. It collects PK samples and clinical data from about 60 infants ≤34 weeks gestation who are receiving empiric ampicillin per standard care, with follow-up up to 30 days or discharge. The study compares short-course dosing to standard empiric therapy in terms of pharmacokinetic exposure and safety. PK samples may be collected around 48 hours and up to 72 hours if other labs are drawn, with informed consent obtained from parents/guardians.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Documented informed consent from parent/guardian
* Infants admitted to the Duke Neonatal Intensive Care Unit (NICU)
* less than or equal to 34 6/7 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 0/7 weeks who have received more than 24 hours of empiric ampicillin OR infants with GA 28 0/7 to 34 6/7 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

Where it's running

• Duke Health Neonatal Intensive Care Unit
  Durham, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Angelique Boutzoukas, MD, MPH
• Email: angelique.boutzoukas@duke.edu
• Phone: 919-668-4733

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.