20 Participants Needed

Amoxicillin for Pregnancy

JW
JD
Overseen ByJodie Dionne-Odom, MD MSPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Amoxicillin is commonly used during pregnancy and is generally considered safe, but studies show mixed results about its effects on the fetus. Some research suggests no significant risk of birth defects or other adverse outcomes, but findings are not entirely consistent.14678

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

JD

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

Able to provide informed consent
Pregnant, engaged in prenatal care with a medical provider (at least one visit)
English speaking
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Exclusion Criteria

My kidney function is impaired with a creatinine level of 1.2 mg/dL or higher.
I haven't taken amoxicillin in the last week.
Known hypersensitivity or intolerance of amoxicillin, penicillin, other beta lactam or cephalosporin antibiotics
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 500 mg oral amoxicillin during the 2nd and 3rd trimester of pregnancy

1-8 hours per administration
Multiple visits for pharmacokinetic sampling

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Amoxicillin
  • Probenecid
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Amox 500 mgExperimental Treatment1 Intervention
Amoxicillin 500 mg PO

Amoxicillin is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Amoxicillin for:
  • Bacterial infections
  • Respiratory tract infections
  • Urinary tract infections
  • Skin and soft tissue infections
  • Ear, nose and throat infections
🇺🇸
Approved in United States as Amoxicillin for:
  • Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract
🇨🇦
Approved in Canada as Amoxicillin for:
  • 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

Trials
1,677
Recruited
2,458,000+

Findings from Research

Amoxicillin clearance rates are significantly higher during pregnancy compared to postpartum, indicating that pregnant women may process the drug differently, which could affect its effectiveness.
Simulations suggest that achieving adequate amoxicillin concentrations to prevent anthrax may be challenging during pregnancy and postpartum, raising concerns about its suitability for anthrax exposure prophylaxis in these populations.
Amoxicillin pharmacokinetics in pregnant women: modeling and simulations of dosage strategies.Andrew, MA., Easterling, TR., Carr, DB., et al.[2022]
A study of 4055 pregnant women in Finland found that penicillin, erythromycin, and pivmecillinam were the most commonly prescribed antibiotics, accounting for 65.4% of all antibiotic use during pregnancy.
The second trimester had the highest rates of antibiotic use and treated infections, suggesting that healthcare providers may need to consider individualized dosing and potentially shorter treatment durations for urinary tract infections to enhance safety and efficacy.
Antibiotics in pregnancy--a prospective cohort study on the policy of antibiotic prescription.Heikkilä, AM.[2019]
In a study of 30 full-term pregnant women, amoxicillin levels were significantly higher in maternal serum (2.18 µg/g) compared to amniotic fluid (0.67 µg/g), umbilical blood (1.00 µg/g), and placenta (1.00 µg/g) two hours after oral administration, indicating limited penetration to fetal tissues.
To effectively treat infections in pregnant patients, especially targeting the fetus and placenta, a higher dose of amoxicillin may be necessary, and intravenous administration should be considered to ensure adequate drug levels.
Evaluation of the amoxicillin concentrations in amniotic fluid, placenta, umbilical cord blood and maternal serum two hours after oral administration.Zareba-Szczudlik, J., Romejko-Wolniewicz, E., Lewandowski, Z., et al.[2018]

References

Amoxicillin pharmacokinetics in pregnant women: modeling and simulations of dosage strategies. [2022]
Antibiotics in pregnancy--a prospective cohort study on the policy of antibiotic prescription. [2019]
Evaluation of the amoxicillin concentrations in amniotic fluid, placenta, umbilical cord blood and maternal serum two hours after oral administration. [2018]
4.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Relationship Between Amoxicillin Use in Pregnancy and Congenital Anomalies: A Systematic Review. [2023]
Amoxicillin treatment of bacterial vaginosis during pregnancy. [2013]
A population-based study of maternal use of amoxicillin and pregnancy outcome in Denmark. [2019]
First-trimester exposure to amoxycillin/clavulanic acid: a prospective, controlled study. [2018]
Birth outcome and risk of neonatal hypoglycaemia following in utero exposure to pivmecillinam: a population-based cohort study with 414 exposed pregnancies. [2019]
A study of cefoxitin, moxalactam, and ceftazidime kinetics in pregnancy. [2019]
Maternal blood and amniotic fluid levels of moxifloxacin, levofloxacin and cefixime. [2018]