Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy

Phase 1

Recruiting

• Conditions: Pregnancy Related
• Interventions: Drug: Amoxicillin

• Registration Number: NCT05309928
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-04-04
• Study Start: 2023-08-29
• Primary Completion: 2025-01-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

1. Pregnant, engaged in prenatal care with a medical provider (at least one visit)
2. Estimated gestational age 24-34 weeks
3. Able to provide informed consent
4. English speaking

Exclusion Criteria

1. 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).
2. Known hypersensitivity or intolerance of amoxicillin, penicillin, other beta lactam or cephalosporin antibiotics.
3. Known renal impairment (serum creatinine ≥1.2 mg/dL).
4. 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amox 500 mg	Amoxicillin	Amoxicillin 500 mg PO

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
additional pharmacologic measures	1-8 hours after administration	1. Maximum concentration (Cmax) in maternal serum.
Additional pharmacologic measure	1-8 hours after administration	time to maximum concentration (tmax) in maternal serum

Trial Locations

Locations (1)

UAB; 🇺🇸 Birmingham, Alabama, United States