Understanding how amoxicillin works in pregnant women
A Rational Approach to the Identification of New Treatment Options to Prevent Congenital Syphilis: Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy
PHASE1 · University of Alabama at Birmingham · NCT05309928
This study tests how well the antibiotic amoxicillin is absorbed in pregnant women during their second and third trimesters to help ensure it's used safely.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 16 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham (other) |
| Drugs / interventions | pembrolizumab, methotrexate |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05309928 on ClinicalTrials.gov |
What this trial studies
This phase 1 pharmacokinetic study aims to evaluate the dosing and absorption of 500 mg oral amoxicillin in pregnant women during their second and third trimesters. The study will enroll twenty healthy pregnant women who are admitted for preterm premature rupture of membranes, collecting essential medical information and monitoring how the drug is processed in their bodies. By focusing on this specific population, the study seeks to provide insights into the appropriate use of amoxicillin during pregnancy.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and older, between 24 to 34 weeks of gestation, who are in good health and able to provide informed consent.
Not a fit: Patients who have received amoxicillin within the past week or have known allergies to beta-lactam antibiotics will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective antibiotic treatment options for pregnant women.
How similar studies have performed: While pharmacokinetic studies in pregnant populations are not uncommon, this specific focus on amoxicillin during pregnancy is relatively novel and may provide new insights.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Birmingham, Alabama
- UAB — Birmingham, Alabama, United States (RECRUITING)
Study contacts
- Principal investigator: Jodie Dionne, MD — University of Alabama at Birmingham
- Study coordinator: Jodie Dionne-Odom, MD MSPH
- Email: jdionne@uabmc.edu
- Phone: 12059756530
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pregnancy Related, pharmacokinetics, amoxicillin