Pregnancy RelatedPhase 1NCT05309928
Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy
A Phase 1 study testing Amoxicillin in people with Pregnancy Related, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2023to 30 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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 information will be collected from the medical record including age, weight, height, pregnancy dating, medications, and allergies.
- Conditions
- Pregnancy Related
- Being tested
- Amoxicillin
- Keywords
- pharmacokinetics, amoxicillin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Also called Probenecid
medication administration
| Study group | Role | What they receive |
|---|---|---|
| Amox 500 mg | Experimental | Amoxicillin 500 mg PO Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Amoxicillin Level in Plasma during Pregnancy
quantitative drug level in blood
Measured: 0, 1, 2, 3, 4, 6, 8 hours after medication administration
Amoxicillin Level in Cord Blood
quantitative drug level in cord blood to calculate transplacental transfer rate for amoxicillin
Measured: at delivery
Change of Amoxicillin Level in Plasma in the Postpartum state
quantitative drug levels in blood to compare to pregnancy state values
Measured: 0, 1, 2, 3, 4, 6, 8 hours after medication administration
Secondary outcomes (2)
additional pharmacologic measures
- Maximum concentration (Cmax) in maternal serum.
Measured: 1-8 hours after administration
Additional pharmacologic measure
time to maximum concentration (tmax) in maternal serum
Measured: 1-8 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start29 Aug 2023
- Primary completion16 Jan 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jodie A. Dionne, MD, University of Alabama at Birmingham
- Investigators
- Jodie Dionne, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309928
- Sponsor's protocol ID
- IRB-300008691
- Other IDs
- UAB
- Status last verified
- Dec 2025
- First submitted
- 14 Mar 2022
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05309928
- Acronym / sponsor ID
- IRB-300008691
- Conditions
- Pregnancy Related
- Keywords
- pharmacokinetics, amoxicillin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- 16 Jan 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 information will be collected from the medical record including age, weight, height, pregnancy dating, medications, and allergies.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Amox 500 mg | Experimental | Drug: AmoxicillinAmoxicillin 500 mg PO |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmoxicillinAlso: Probenecidmedication administration | Drug | Amox 500 mg |
Primary outcome
Change of Amoxicillin Level in Plasma during Pregnancy
Time frame: 0, 1, 2, 3, 4, 6, 8 hours after medication administration
quantitative drug level in blood
Amoxicillin Level in Cord Blood
Time frame: at delivery
quantitative drug level in cord blood to calculate transplacental transfer rate for amoxicillin
Change of Amoxicillin Level in Plasma in the Postpartum state
Time frame: 0, 1, 2, 3, 4, 6, 8 hours after medication administration
quantitative drug levels in blood to compare to pregnancy state values
2 secondary outcomes
additional pharmacologic measures
Time frame: 1-8 hours after administration
Additional pharmacologic measure
Time frame: 1-8 hours after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jodie Dionne, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amoxicillin in people with Pregnancy Related, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Amoxicillin Level in Plasma during Pregnancy (time frame: 0, 1, 2, 3, 4, 6, 8 hours after medication administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.