Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Mar 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how the body processes a common antibiotic called amoxicillin in pregnant women during their second and third trimesters. The researchers want to learn more about the best dosage for pregnant women who may need this medication, particularly since pregnancy can change how medicines work in the body. The trial is currently looking for women who are between 24 and 34 weeks pregnant and have been visiting their healthcare provider for prenatal care. Participants must be able to understand and provide consent in English.

If you decide to join the study, you will take a 500 mg dose of amoxicillin, and the researchers will monitor how your body absorbs and reacts to it. It's important to note that women who have taken amoxicillin in the past week, have certain allergies or medical conditions, or are on specific medications that can interact with amoxicillin may not be eligible to participate. This study aims to ensure that amoxicillin is safe and effective for pregnant women, which can help doctors make better treatment decisions in the future.

Gender

FEMALE

Eligibility criteria

• 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).