Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy

Last updated: April 7, 2025
Sponsor: University of Alabama at Birmingham
Overall Status: Active - Recruiting

Phase

1

Condition

Rash

Sexually Transmitted Diseases (Stds)

Gynecological Infections

Treatment

Amoxicillin

Clinical Study ID

NCT05309928
IRB-300008691
  • Ages 16-50
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Receipt of amoxicillin within the past 7 days. (Routine GBS prophylaxis withampicillin or other antibiotic and routine surgical prophylaxis prior to cesareanwith cephalexin and azithromycin 500 mg IV is allowed).

  2. Known hypersensitivity or intolerance of amoxicillin, penicillin, other beta lactamor 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

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Amoxicillin
Phase: 1
Study Start date:
August 29, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • UAB

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.