Oral Amoxicillin and Cephalexin PK/PD in Neonates

NCT04916951 | Unknown Phase 1 FDA Drug

• 1 other identifier: 20-2877
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Neonatal Infection

Outcome Measures

Primary Outcomes (1)

• Time above Minimum Inhibitory Concentration (T > MIC)

  As a surrogate of treatment efficacy for amoxicillin and cephalexin, the investigators will determine the time that free plasma concentrations (fT \> MIC) of amoxicillin and cephalexin remain above the minimum inhibitory concentration (MIC) of common neonatal pathogens. Monte Carlo simulation will be used to assess for the likelihood of fT \> MIC dosing goals.

  up to 24 hours

Secondary Outcomes (7)

• Clearance (CL/F) of amoxicillin and cephalexin

  Plasma drug concentrations obtained within 12 hours of a dose

• Volume of Distribution (V/F) of amoxicillin and cephalexin

  Plasma drug concentrations obtained within 12 hours of a dose

• Half life (T1/2) of amoxicillin and cephalexin

  Plasma drug concentrations obtained within 12 hours of a dose

• Area under the curve (AUC) of amoxicillin and cephalexin

  Plasma drug concentrations obtained within 12 hours of a dose

• Peak serum drug concentration (Cmax) of amoxicillin and cephalexin

  Plasma drug concentrations obtained within 12 hours of a dose

Study Arms (4)

Amoxicillin - standard-of-care dose

NO INTERVENTION

Obtain amoxicillin plasma concentrations in patients already receiving amoxicillin

Cephalexin - standard-of-care dose

NO INTERVENTION

Obtain cephalexin plasma concentrations in patients already receiving cephalexin

Amoxicillin - study dose

EXPERIMENTAL

Obtain amoxicillin plasma concentrations after a study-administered dose of amoxicillin

Drug: Amoxicillin

Cephalexin - study dose

EXPERIMENTAL

Obtain cephalexin plasma concentrations after a study-administered dose of cephalexin

Drug: Cephalexin

Interventions

Amoxicillin DRUG

oral one-time dose of amoxicillin

Amoxicillin - study dose

Cephalexin DRUG

oral one-time dose of cephalexin

Cephalexin - study dose

Eligibility Criteria

• Age: 1 Day - 60 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

Amoxicillin; Cephalexin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cephalosporins; Thiazines

Study Officials

• Andrew Haynes, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 8, 2021
• Study Start: July 14, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)