Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy

Study Overview
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Brief Summary
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The study design is a prospective phase I pharmacokinetic study focused on dosing of 500 mg oral amoxicillin administration in pregnant women in the 2nd and 3rd trimester.

Detailed Description
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Twenty adult pregnant women in good health who are admitted for preterm premature rupture of membranes (24-34 weeks gestational age) will be enrolled in this intensive pharmacokinetic study. Basic information will be collected from the medical record including age, weight, height, pregnancy dating, medications, and allergies.

Official Title
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A Rational Approach to the Identification of New Treatment Options to Prevent Congenital Syphilis: Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy

Conditions
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Pregnancy Related

Intervention / Treatment
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* Drug: Amoxicillin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant, engaged in prenatal care with a medical provider (at least one visit) Estimated gestational age 24-34 weeks Able to provide informed consent English speaking Exclusion Criteria: Receipt of amoxicillin within the past 7 days. (Routine GBS prophylaxis with ampicillin or other antibiotic and routine surgical prophylaxis prior to cesarean with cephalexin and azithromycin 500 mg IV is allowed). Known hypersensitivity or intolerance of amoxicillin, penicillin, other beta lactam or cephalosporin antibiotics. 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).

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: The study design is a prospective phase I pharmacokinetic study focused on dosing of 500 mg oral amoxicillin administration in pregnant women in the 2nd and 3rd trimester.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amox 500 mg<br>Amoxicillin 500 mg PO | Drug: Amoxicillin<br>* medication administration<br>* Other names: Probenecid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Amoxicillin Level in Plasma during Pregnancy | quantitative drug level in blood | 0, 1, 2, 3, 4, 6, 8 hours after medication administration | 
| Amoxicillin Level in Cord Blood | quantitative drug level in cord blood to calculate transplacental transfer rate for amoxicillin | at delivery | 
| Change of Amoxicillin Level in Plasma in the Postpartum state | quantitative drug levels in blood to compare to pregnancy state values | 0, 1, 2, 3, 4, 6, 8 hours after medication administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| additional pharmacologic measures | 1. Maximum concentration (Cmax) in maternal serum. | 1-8 hours after administration | 
| Additional pharmacologic measure | time to maximum concentration (tmax) in maternal serum | 1-8 hours after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, amoxicillin