Amoxicillin for Pregnancy
Recruiting in Palo Alto (17 mi)
Overseen byJodie Dionne, MD
Age: < 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: University of Alabama at Birmingham
Must not be taking: Allopurinol, Methotrexate, Tetracyclines, others
Disqualifiers: Renal impairment, Amoxicillin allergy, others
No Placebo Group
Approved in 3 Jurisdictions
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.
12345Is 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.
14678How 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.
134910Eligibility 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
+1 more
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
+1 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
UABBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
References
Amoxicillin pharmacokinetics in pregnant women: modeling and simulations of dosage strategies. [2022]Amoxicillin is recommended for anthrax prevention in pregnancy. The objective of this study was to evaluate the pharmacokinetics of amoxicillin during pregnancy and postpartum (PP). Sixteen women received amoxicillin during gestation (18-22 weeks (T2) and 30-34 weeks (T3)) as well as 3 months postpartum (PP) to evaluate single-dose pharmacokinetics. Amoxicillin compartmental pharmacokinetic parameters were used to simulate amoxicillin concentration-time profiles following different dosage strategies. Amoxicillin CL(renal) (T2: 24.8+/-6.7 l/h, P
Antibiotics in pregnancy--a prospective cohort study on the policy of antibiotic prescription. [2019]Pregnancy is associated with special problems with respect to antibiotic selection and dosage due to potential teratogenic or toxic effects on the fetus by the drug itself, and the great physiological adjustments in the mother. This survey was designed to record the use of antibiotics and the policy of prescription of antimicrobial drugs during the course of pregnancy. In total, 4055 pregnant women residing in a county in south-western Finland during the period June 15, 1987-June 14, 1988 were studied. Penicillin, erythromycin and pivmecillinam were the most often used antibiotics during pregnancy comprising together 65.4% of all antibiotic use; 94.1% of all antimicrobial medication was administered orally. The highest incidence for antibiotic use (45.4% of all) as well as for treated infections (45% of all) was at the second trimester. The duration of medication was commonly 10 days (44.4%, SD 14.6) or 7 days (27.9%, SD 7.7). Penicillin was in a few cases prescribed at increased dosage (25.6%), while erythromycin and amoxicillin were occasionally administered at reduced dosages (30.2% and 42.5%, respectively). The dosages should probably be individualized more often, according to the information available on the pharmacokinetics of specific antibiotics during pregnancy. It may also be possible to reduce the length of antibiotic treatment for UTI.
Evaluation of the amoxicillin concentrations in amniotic fluid, placenta, umbilical cord blood and maternal serum two hours after oral administration. [2018]Amoxicillin is a broad-spectrum beta-lactam antibiotic. Due to its low toxicity, it is commonly used in obstetrics. The objective of this study was to assess amoxicillin concentrations in amniotic fluid, umbilical blood, placenta and maternal serum two hours following oral administration among pregnant women at term and to assess obstetric and non-obstetric factors that might affect amoxicillin's penetration of these tissues.
Relationship Between Amoxicillin Use in Pregnancy and Congenital Anomalies: A Systematic Review. [2023]Amoxicillin is among the most used antibiotics in the treatment of a wide spectrum of bacterial infections. Although amoxicillin is categorized as group B in pregnancy, the findings of studies regarding its effects on the fetus are controversial. The aim of this systematic review was to review the reported effects of amoxicillin administration in pregnancy on congenital anomalies.
Amoxicillin treatment of bacterial vaginosis during pregnancy. [2013]The purpose of this investigation was to evaluate the efficacy of amoxicillin for treatment of bacterial vaginosis during pregnancy. The diagnosis of bacterial vaginosis was established by clinical examination and microscopic examination of a Gram stain and saline preparation of vaginal secretions. In a double-blind, randomized manner, 108 patients at 15-25 weeks' gestation were assigned to treatment with oral amoxicillin, 500 mg three times daily for 14 days, or placebo. Patients were evaluated 2 weeks after treatment, at 34-36 weeks' gestation, and at delivery. There were no significant differences between the two groups with respect to any clinical or microbiologic measure of treatment outcome. There were also no significant differences in the frequency of obstetric complications. We conclude that amoxicillin is not effective therapy for bacterial vaginosis in pregnant women.
A population-based study of maternal use of amoxicillin and pregnancy outcome in Denmark. [2019]Amoxicillin is a widely used penicillin, but data on its safety in pregnancy are limited. We examined the association between amoxicillin exposure during pregnancy and birth weight, preterm delivery, congenital malformations, perinatal death, and spontaneous abortion.
First-trimester exposure to amoxycillin/clavulanic acid: a prospective, controlled study. [2018]The number of published studies on the use of amoxycillin/clavulanic acid during pregnancy is small and so is the number of pregnancies investigated in those studies. In this study we wished to investigate prospectively the safety of intrauterine exposure to amoxycillin/clavulanic acid in a relatively large cohort of women.
Birth outcome and risk of neonatal hypoglycaemia following in utero exposure to pivmecillinam: a population-based cohort study with 414 exposed pregnancies. [2019]Concerns have been raised as to the safety of using pivaloyl-conjugated beta-lactam antibiotics during pregnancy as they cause carnitine depletion. Restrictions have been recommended in some Scandinavian countries as drug-induced carnitine depletion could constitute a risk to the developing foetus. One of these drugs, pivmecillinam, is widely used against urinary tract infections but few data exist concerning its safety in pregnancy. In a cohort study, we compared the prevalences of congenital abnormalities, pre-term delivery, low birth weight, low Apgar score and neonatal hypoglycaemia in the offspring of 414 women who had at least 1 prescription for pivmecillinam redeemed during pregnancy with those of the offspring of 7472 pregnant women for whom no drugs were prescribed during pregnancy. The prevalence of congenital abnormalities was 1.7% among 119 infants exposed in the first trimester and 3.7% among the reference group [odds ratio (OR) 0.46; 95% confidence interval (CI) 0.11-1.86]. We found no significantly increased risks in either pre-term delivery (OR 0.91, 95% CI 0.11-1.86), low birth weight (OR 0.57, 95%, CI 0.23-1.41), low Apgar score (OR 2.32, 95% CI 0.30-18.16) or hypoglycaemia (OR 0.73, 95% CI 0.18-3.00) that were induced by carnitine depletion. No significantly increased risk in adverse birth outcome was therefore found in women treated with pivmecillinam.
A study of cefoxitin, moxalactam, and ceftazidime kinetics in pregnancy. [2019]In 27 women with fetuses affected by beta-thalassemia major, termination of gestation between 19 and 21 weeks was induced by amniocentesis and intrauterine instillation of prostaglandin F2 alpha. Pharmacokinetics in maternal blood and amniotic fluid were studied after at least three doses of one of the following antibiotics and before prostaglandin F2 alpha infusion: (1) cefoxitin, 2 gm, intravenously, 1/2-hour infusion, three times per day; (2) moxalactam, 2 gm, intravenously, 1/2-hour infusion, three times per day; and (3) ceftazidime, 1 gm, intramuscularly, three times per day. Successful amniotic fluid levels effective against various pathogens implicated in maternal-fetal infections appeared at least 3 hours beyond administration of the drug and ranged between 2.3 and 6.7 micrograms/ml, 1.56 and 15 micrograms/ml, and 1.5 and 5 micrograms/ml for cefoxitin, moxalactam, and ceftazidime, respectively. Beyond the third-hour after infusion a percentage ratio of amniotic fluid to simultaneous maternal serum level of almost greater than or equal to 50 was constantly observed for all studied antibiotics. Cefoxitin serum levels were about the same as those in nonpregnant women, while moxalactam and ceftazidime serum levels were 50% lower than the expected level in normal individuals.
Maternal blood and amniotic fluid levels of moxifloxacin, levofloxacin and cefixime. [2018]Moxifloxacin and levofloxacin are wide spectrum quinolones and cefixime is a third-generation cephalosporin with a wider spectrum of activity against gram-positive and gram-negative bacteria and anaerobics. Although they are widely used, little is known about the amniotic fluid levels of these antibiotics. The aim of the present investigation was to study and compare the maternal blood and amniotic fluid levels of these antibiotics in second trimester pregnancy.