Status:
UNKNOWN
Oral Amoxicillin and Cephalexin PK/PD in Neonates
Lead Sponsor:
University of Colorado, Denver
Conditions:
Neonatal Infection
Eligibility:
All Genders
1-60 years
Phase:
PHASE1
Brief 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...
Detailed Description
This proposal's objective is to evaluate the pharmacokinetics and pharmacodynamics (PK/PD) of enteral amoxicillin and cephalexin in neonates and young infants admitted to the hospital, characterize ag...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04916951
Start Date
July 14 2021
End Date
June 1 2024
Last Update
December 11 2023
Active Locations (1)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045