CompletedPhase 1

Oral Amoxicillin and Cephalexin PK/PD in Neonates

United States72 participantsStarted 2021-07-14

Plain-language summary

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.

Who can participate

Age range

1 Day – 60 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time above Minimum Inhibitory Concentration (T > MIC)

Timeframe: up to 24 hours

Trial details

NCT IDNCT04916951

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-30

View on ClinicalTrials.gov More Neonatal Infection trials