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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

Study 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).Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time above Minimum Inhibitory Concentration (T > MIC)
Secondary outcome measures
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

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
1,732 Previous Clinical Trials
2,143,523 Total Patients Enrolled
Andrew Haynes, MDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus
1 Previous Clinical Trials
17 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experimental research open to participants under the age of thirty?

"This research is open to individuals who are over 1 Day years old and younger than 60 Days of age."

Answered by AI

What potential dangers come with taking Amoxicillin?

"Due to its Phase 1 status, the potential risk associated with Amoxicillin is assessed as low, giving it a score of 1."

Answered by AI

Is there still availability for participation in this investigation?

"Unfortunately, this medical trial is not currently recruiting. It was initially posted on July 14th 2021 and last updated November 2nd 2022. For those seeking alternative research opportunities, there are 3 clinical trials searching for participants with neonatal infections and 66 studies related to amoxicillin that require enrolment."

Answered by AI

Does this experiment offer the opportunity for me to participate?

"This trial has room for 60 neonates aged from 1 Day to 60 Days old that are diagnosed with infections and receiving intravenous antibiotics while being able to tolerate full enteral feeds or medications."

Answered by AI

What is the aggregate count of participants entering this experiment?

"This clinical study is no longer recruiting new patients. It was first posted on July 14th 2021 and last updated on November 2nd 2022. Alternatively, individuals may investigate 3 trials for neonatal infections or 66 studies involving Amoxicillin that are still seeking participants."

Answered by AI

In what clinical settings is Amoxicillin typically prescribed?

"Amoxicillin is a commonly prescribed antibiotic for treating bacterial infections, otitis media (OM), and urinary tract infection."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Oral Amoxicillin and Cephalexin PK/PD in Neonates
2021. "Oral Amoxicillin and Cephalexin PK/PD in Neonates". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04916951.
~2 spots leftby Jun 2024
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