Status:
COMPLETED
Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Pregnancy Related
Eligibility:
FEMALE
16-50 years
Phase:
PHASE1
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.
Detailed 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 inf...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05309928
Start Date
August 29 2023
End Date
June 30 2025
Last Update
December 17 2025
Active Locations (1)
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1
UAB
Birmingham, Alabama, United States, 35294