Optimizing PreTerm Infant Ampicillin Dosing
Recruiting
Phase 1
Phase 2
Interventional Study
Early Onset Sepsis
Preterm Neonates
NICU
Ampicillin
Safety and Pharmacokinetics
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 0 Days – 7 Days
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Duke University · Other
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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?
Pr…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
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 stand…
Contacts