Pharmacokinetic (PK) and Pharmacodynamic (PD) Modeling of Ampicillin and Gentamicin in Peripartum Patients
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | May 2015 |
| End Date: | May 2017 |
| Contact: | Brendan Carvalho, MBBCh |
| Email: | bcarvalho@stanford.edu |
| Phone: | 650-861-8607 |
PK and PD Modeling of Ampicillin and Gentamicin in Peripartum Patients
This study proposes to compare the metabolism of Ampicillin and Gentamicin by pregnant women
to that of non-pregnant women; the placental transfer over time; and the subsequent
metabolism of the transferred drug(s) in the neonate.
to that of non-pregnant women; the placental transfer over time; and the subsequent
metabolism of the transferred drug(s) in the neonate.
Pregnant women who present to Labor and Delivery will be identified as potential
participants based on Inclusion/Exclusion criteria and their need to receive Ampicillin
and/or Gentamicin therapy. The additional group of 20 non-pregnant women will also be
identified based on Inclusion/Exclusion criteria and their need to receive Ampicillin and/or
Gentamicin therapy.
Once identified, interested candidates will be fully informed of the study procedures, have
all questions answered, and informed consent obtained.
Pregnant participants will receive Ampicillin 2g IV loading dose followed by 1g IV every 4
hrs until delivery; or Ampicillin 2g IV every 6hrs along with Gentamicin 5mg/kg IV every 24
hrs. Dose times will be recorded.
Non-pregnant participants will receive similar doses of either Ampicillin and/or Gentamicin,
if not the same dose(s).
Fingerstick blood collection will be drawn from both populations at the following
timepoints:
- before the administration of Ampicillin, and/or
- before the administration of Gentamicin
- after the full initial dose of the antibiotic has infused, at 5 min, 15 min, 30 min,
2-3hr, 4-6hr, immediately prior to the next dose of drug, and at DELIVERY (a 5 minute
window for each timepoint will be permitted) If delivery occurs prior to the 3 or 6 hr
timepoints, fingerstick blood collection should continue
Samples will be obtained on filter paper via the Dry Blood Spot (DBS) method, which is
clinically appropriate for the purposes of this study.
Umbilical venous and arterial blood will also be drawn for sampling from the placenta after
delivery, and cutting of the umbilical cord.
participants based on Inclusion/Exclusion criteria and their need to receive Ampicillin
and/or Gentamicin therapy. The additional group of 20 non-pregnant women will also be
identified based on Inclusion/Exclusion criteria and their need to receive Ampicillin and/or
Gentamicin therapy.
Once identified, interested candidates will be fully informed of the study procedures, have
all questions answered, and informed consent obtained.
Pregnant participants will receive Ampicillin 2g IV loading dose followed by 1g IV every 4
hrs until delivery; or Ampicillin 2g IV every 6hrs along with Gentamicin 5mg/kg IV every 24
hrs. Dose times will be recorded.
Non-pregnant participants will receive similar doses of either Ampicillin and/or Gentamicin,
if not the same dose(s).
Fingerstick blood collection will be drawn from both populations at the following
timepoints:
- before the administration of Ampicillin, and/or
- before the administration of Gentamicin
- after the full initial dose of the antibiotic has infused, at 5 min, 15 min, 30 min,
2-3hr, 4-6hr, immediately prior to the next dose of drug, and at DELIVERY (a 5 minute
window for each timepoint will be permitted) If delivery occurs prior to the 3 or 6 hr
timepoints, fingerstick blood collection should continue
Samples will be obtained on filter paper via the Dry Blood Spot (DBS) method, which is
clinically appropriate for the purposes of this study.
Umbilical venous and arterial blood will also be drawn for sampling from the placenta after
delivery, and cutting of the umbilical cord.
Inclusion Criteria:
- Generally healthy, pregnant woman (28-42 weeks)
- Generally healthy, non-pregnant female
- Scheduled to receive Ampicillin and/or Gentamicin IV
- Ages 18-55 years old
- Relatively normal Comprehensive Metabolic Panel (if available), as evidenced by
recent blood work
- Able and willing to sign consent
Exclusion Criteria:
- Women with known renal or hepatic impairment; preeclampsia; Diabetes, including
Gestational; any medical condition that, in the opinion of the Investigator or
research team member, could potentially interfere with the study objectives
- Women who are participating in another study
- Pregnant with multiples
- BMI > 40
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