Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy

NCT05309928 | Completed Phase 1 FDA Drug

• 2 other identifiers: IRB-300008691UAB
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Keywords

pharmacokinetics; amoxicillin

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• additional pharmacologic measures

  1-8 hours after administration

• Additional pharmacologic measure

  1-8 hours after administration

Study Arms (1)

Amox 500 mg

EXPERIMENTAL

Amoxicillin 500 mg PO

Drug: Amoxicillin

Interventions

Amoxicillin DRUG

medication administration

Also known as: Probenecid

Amox 500 mg

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Interventions

Amoxicillin; Probenecid

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; Sulfonamides; Sulfones

Study Officials

• Jodie Dionne, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine; Division of Infectious Diseases

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 4, 2022
• Study Start: August 29, 2023
• Primary Completion: January 16, 2025
• Study Completion: June 30, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)