Amoxicillin for Pregnancy
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
You may need to stop taking certain medications that interact with amoxicillin, such as allopurinol, methotrexate, and warfarin. It's important to discuss your current medications with the trial team to see if any changes are needed.
What data supports the effectiveness of the drug amoxicillin for use during pregnancy?
Amoxicillin is commonly used in pregnancy due to its low toxicity and is recommended for anthrax prevention. It is a broad-spectrum antibiotic, meaning it can treat a wide range of bacterial infections, and studies have shown it is often used during pregnancy without significant adverse effects.12345
Is amoxicillin safe to use during pregnancy?
How is the drug amoxicillin unique for use during pregnancy?
Amoxicillin is unique for use during pregnancy because it is a broad-spectrum antibiotic with low toxicity, making it commonly used in obstetrics. It is also recommended for anthrax prevention in pregnancy, and studies have evaluated its pharmacokinetics to optimize dosage strategies for pregnant women.134910
Research Team
Jodie Dionne, MD
Principal Investigator
University of Alabama at Birmingham
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 500 mg oral amoxicillin during the 2nd and 3rd trimester of pregnancy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Amoxicillin
- Probenecid
Amoxicillin is already approved in European Union, United States, Canada for the following indications:
- Bacterial infections
- Respiratory tract infections
- Urinary tract infections
- Skin and soft tissue infections
- Ear, nose and throat infections
- Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract
- Bacterial infections
- Respiratory tract infections
- Urinary tract infections
- Skin and soft tissue infections
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor