Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy

Completed · Phase 1

Conditions studied: Pregnancy Related

In brief

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.

Key facts

Study ID

NCT05309928

Run by

University of Alabama at Birmingham

People needed

13

Starts

2023-08-29

Expected to finish

2025-06-30

Last updated by the study team

2025-12-17

Who can join

Age: 16 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

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).

Where it is running

• UAB — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.