Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy

The University of Alabama at Birmingham

Status and phase

Enrolling

Phase 1

Conditions

Pregnancy Related

Treatments

Drug: Amoxicillin

Study type

Interventional

Funder types

Other

Identifiers

NCT05309928

IRB-300008691

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

Female

Ages

16 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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).