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Penicillin Antibiotic

Amoxicillin for Pregnancy

Phase 1
Recruiting
Led By Jodie Dionne, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Must not have
Known renal impairment (serum creatinine ≥1.2 mg/dL)
Active concomitant medications known to interact with amoxicillin: allopurinol, methotrexate, mycophenolate, immune checkpoint inhibitors (ie. pembrolizumab), tetracyclines (ie. doxycycline), vitamin K antagonists (ie. warfarin), aminoglycosides (ie. gentamicin)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at delivery
Awards & highlights
No Placebo-Only Group

Summary

This trial studies the safety and best dose of an antibiotic given to pregnant women in the 2nd and 3rd trimester.

Who is the study for?
This trial is for pregnant women in their 2nd or 3rd trimester who are under prenatal care and can speak English. They must not have taken amoxicillin recently, be allergic to it or similar antibiotics, have high creatinine levels indicating kidney issues, or be on certain drugs that don't mix well with amoxicillin.
What is being tested?
The study is testing how the body processes a dose of 500 mg oral amoxicillin when given to pregnant women. It's a phase I trial which means it's early in the testing process and focuses on understanding how the drug moves through and affects pregnant bodies.
What are the potential side effects?
Amoxicillin may cause side effects like allergic reactions (rash, swelling), gastrointestinal upset (nausea, vomiting), and less commonly severe skin reactions or liver problems. Side effects might differ during pregnancy.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My kidney function is impaired with a creatinine level of 1.2 mg/dL or higher.
Select...
I am not taking medications that interact with amoxicillin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-8 hours after administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-8 hours after administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Amoxicillin Level in Cord Blood
Change of Amoxicillin Level in Plasma during Pregnancy
Change of Amoxicillin Level in Plasma in the Postpartum state
Secondary study objectives
Additional pharmacologic measure
additional pharmacologic measures

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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Amox 500 mgExperimental Treatment1 Intervention
Amoxicillin 500 mg PO
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amoxicillin
2017
Completed Phase 4
~7780

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,364 Total Patients Enrolled
Jodie Dionne, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
~0 spots leftby Dec 2024
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