Oral Amoxicillin and Cephalexin PK/PD in Neonates

Completed · Phase 1

Conditions studied: Neonatal Infection

In brief

The goal of this study is to figure out the best doses for two oral antibiotics (called amoxicillin and cephalexin) when they are used to treat infections in newborns and young infants. In order to do this, the study plans to enroll two groups of young infants who are admitted to the Children's Hospital Colorado. In the first group, infants already receiving one of these two antibiotics will be enrolled. Over a few days in the hospital, up to 5 blood samples will be collected from each infant to measure how much of the drug is in their body at different points in time after a dose. In the second group, infants who are already receiving an IV antibiotic and who are eating normally or receiving oral medications will be enrolled. These infants will receive one dose by mouth of either amoxicillin or cephalexin, in addition to the IV antibiotic already being used to treat their infection. After the oral antibiotic dose,blood will be drawn every few hours to measure how much of the drug is still in their body. Blood levels of the antibiotics will be used to calculate how much and how often both antibiotics would need to be given to treat a variety of infections that are common in infants. The study will calculate if using a single blood level can predict whether or not an infant might be at risk of the antibiotic not working well enough for them.

Key facts

Study ID: NCT04916951
Run by: University of Colorado, Denver
People needed: 72
Starts: 2021-07-14
Expected to finish: 2025-11-30
Last updated by the study team: 2026-05-19

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients admitted to Children's Hospital Colorado derived from two groups:
Group 1-patients specifically receiving enteral amoxicillin (with or without clavulanate) or cephalexin for any clinical indication;
Group 2-patients receiving any IV antibiotic who are tolerating full enteral feeds and/or enteral medications.

You may not qualify if…

Across both groups, exclusion criteria are: (1) weight <2kg, (2) renal dysfunction, including the use of any renal replacement therapy, (3) significant β-lactam allergy, (4) GI disorders significantly impairing drug absorption, (5) use of external circuits that would affect the study drug's volume of distribution (e.g. ECMO), and (6) clinically significant anemia precluding study-related blood draws.

Where it is running

Children's Hospital Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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