Phase 1 Study of the Pharmacokinetics of High Dose Amoxicillin With and Without Probenecid in Pregnant Women

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

This phase I pharmacokinetic study compares four medication regimens (high or low dose amoxicillin +/- probenecid) in 40 healthy pregnant women at the time of delivery. The goal of the study is to assess medication safety and efficacy as measured by the attainment of therapeutic levels in maternal serum and amniotic fluid. This information will be used to identify a dosing regimen that is expected to reach therapeutic levels in maternal and fetal compartments. In future trials, effective dosing strategies identified can be tested in women with syphilis in pregnancy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Amoxicillin; Probenecid

Criteria

Inclusion Criteria:

1. Pregnant, engaged in prenatal care with a medical provider (at least one visit)

2. Estimated gestational age ≥ 35 weeks

3. Able to provide informed consent

4. English speaking

Exclusion Criteria:

1. Receipt of amoxicillin or probenecid within the past 7 days. (Routine GBS prophylaxis with ampicillin or other antibiotic and routine surgical prophylaxis prior to cesarean is allowed).

2. Known hypersensitivity or intolerance of amoxicillin, penicillin, other beta lactam or cephalosporin antibiotics or probenecid.

3. Spontaneous rupture of membranes prior to enrollment.

4. Known renal impairment (serum creatinine ≥1.0 mg/dL).

5. 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).