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Penicillin Antibiotic

Amoxicillin for Pregnancy

Phase 1

Recruiting

Led By Jodie Dionne, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at delivery

Awards & highlights

Study Summary

This trial studies the safety and best dose of an antibiotic given to pregnant women in the 2nd and 3rd trimester.

Who is the study for?

This trial is for pregnant women in their 2nd or 3rd trimester who are under prenatal care and can speak English. They must not have taken amoxicillin recently, be allergic to it or similar antibiotics, have high creatinine levels indicating kidney issues, or be on certain drugs that don't mix well with amoxicillin.Check my eligibility

What is being tested?

The study is testing how the body processes a dose of 500 mg oral amoxicillin when given to pregnant women. It's a phase I trial which means it's early in the testing process and focuses on understanding how the drug moves through and affects pregnant bodies.See study design

What are the potential side effects?

Amoxicillin may cause side effects like allergic reactions (rash, swelling), gastrointestinal upset (nausea, vomiting), and less commonly severe skin reactions or liver problems. Side effects might differ during pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-8 hours after administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-8 hours after administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-8 hours after administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Amoxicillin Level in Cord Blood

Change of Amoxicillin Level in Plasma during Pregnancy

Change of Amoxicillin Level in Plasma in the Postpartum state

Secondary outcome measures

Additional pharmacologic measure

additional pharmacologic measures

Trial Design

1Treatment groups

Experimental Treatment

Group I: Amox 500 mgExperimental Treatment1 Intervention

Amoxicillin 500 mg PO

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Amoxicillin

2017

Completed Phase 4

~7780

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,642 Total Patients Enrolled

Jodie Dionne, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial admit individuals aged eighty-five or above?

"The eligibility requirements for this investigation necessitate that applicants are between 16 and 50 years of age. In addition, there are 25 studies specifically designed to accommodate minors and 81 exclusive trials for those over the senior threshold."

Answered by AI

Is Amox 500 mg a reliable medication with minimal adverse effects?

"Our experts at Power rated the safety of Amox 500 mg to be a 1, due to it being an experimental Phase 1 trial with minimal data regarding its efficacy and security."

Answered by AI

Who is eligible for enrollment in this experiment?

"This experiment requires 20 pregnant women aged between 16 and 50 to participate. The prerequisites for potential candidates are as follows: Currently expecting, Engaged in prenatal care with an accredited physician (at least one visit), Between 35 - 40 weeks gestation, Agreeable to sign informed consent forms, Proficient in English."

Answered by AI

Are there any opportunities for individuals to participate in this research endeavor at present?

"This research trial, posted on August 29th 2023 and revised September 10th of the same year, is actively seeking enrollees according to clinicaltrials.gov's information."

Answered by AI

What is the aggregate participation rate for this research endeavor?

"Affirmative. Data accessible on clinicaltrials.gov demonstrates that this medical experiment, which was initially made available to public view on 8/29/2023, is actively seeking out participants. Approximately 20 patients need to be recruited from 1 particular location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy

Jodie A. Dionne, MD 2023. "Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05309928.

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