Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy

Pregnancy Related Clinical Trial

Official title:

A Rational Approach to the Identification of New Treatment Options to Prevent Congenital Syphilis: Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05309928
• Other study ID #: IRB-300008691
• Status: Recruiting
• Phase: Phase 1
• Start date: August 29, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: September 2023
• Source: University of Alabama at Birmingham
• Contact: Jodie Dionne-Odom, MD MSPH
• Phone: 12059756530
• Email: jdionne[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Drug:
• Amoxicillin
medication administration

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Amoxicillin Level in Plasma during Pregnancy	quantitative drug level in blood	0, 1, 2, 3, 4, 6, 8 hours after medication administration
Primary	Amoxicillin Level in Cord Blood	quantitative drug level in cord blood to calculate transplacental transfer rate for amoxicillin	at delivery
Primary	Change of Amoxicillin Level in Plasma in the Postpartum state	quantitative drug levels in blood to compare to pregnancy state values	0, 1, 2, 3, 4, 6, 8 hours after medication administration
Secondary	additional pharmacologic measures	1. Maximum concentration (Cmax) in maternal serum.	1-8 hours after administration
Secondary	Additional pharmacologic measure	time to maximum concentration (tmax) in maternal serum	1-8 hours after administration