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Beta-Lactam Antibiotic

Amoxicillin for Neonatal Infections

Phase 1
Waitlist Available
Led By Andrew Haynes, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is studying two oral antibiotics, amoxicillin and cephalexin, to treat infections in newborns and young infants. The study will enroll two groups of infants, those already receiving one of the antibiotics and those receiving IV antibiotics, to test different doses of the antibiotics. Blood will be drawn to measure how much of the drug is in the body at different times after a dose. The study will calculate if using a single blood level can predict whether or not an antibiotic will work for an infant.

Who is the study for?
This trial is for newborns and young infants with infections, admitted to Children's Hospital Colorado. It includes those already taking oral amoxicillin or cephalexin (Group 1), and those on IV antibiotics but can take oral meds (Group 2).
What is being tested?
The study tests the best doses of two antibiotics, amoxicillin and cephalexin, in treating infant infections. Infants will have blood samples taken after dosing to measure drug levels and determine effective dosing schedules.
What are the potential side effects?
While not detailed here, common side effects of amoxicillin and cephalexin may include allergic reactions, digestive upset like diarrhea or vomiting, rash, and rarely more serious reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time above Minimum Inhibitory Concentration (T > MIC)
Secondary study objectives
Area under the curve (AUC) of amoxicillin and cephalexin
Clearance (CL/F) of amoxicillin and cephalexin
Half life (T1/2) of amoxicillin and cephalexin
+4 more

Side effects data

From 2023 Phase 4 trial • 23 Patients • NCT05010304
9%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pediatric Patients With a History of Penicillin Allergy

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Cephalexin - study doseExperimental Treatment1 Intervention
Obtain cephalexin plasma concentrations after a study-administered dose of cephalexin
Group II: Amoxicillin - study doseExperimental Treatment1 Intervention
Obtain amoxicillin plasma concentrations after a study-administered dose of amoxicillin
Group III: Amoxicillin - standard-of-care doseActive Control1 Intervention
Obtain amoxicillin plasma concentrations in patients already receiving amoxicillin
Group IV: Cephalexin - standard-of-care doseActive Control1 Intervention
Obtain cephalexin plasma concentrations in patients already receiving cephalexin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amoxicillin
FDA approved
Cephalexin
FDA approved

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,808 Previous Clinical Trials
2,822,180 Total Patients Enrolled
Andrew Haynes, MDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus
1 Previous Clinical Trials
17 Total Patients Enrolled
~14 spots leftby Dec 2025
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