Clinical trial NCT02427932: Pharmacokinetic (PK) and Pharmacodynamic (PD) Modeling of Ampicillin and Gentamicin in Peripartum Patients
Official title: PK and PD Modeling of Ampicillin and Gentamicin in Peripartum Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Metabolism During Pregnancy
Keywords: Pharmacokinetics (PK)
Pharmacodynamics (PD)
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: David Drover, MD
First posted: 2015-04-28
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women receiving ampicillin or gentamicin

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetic Profiling to Measure Maternal Metabolism of Ampicillin and/or Gentamicin in Pregnancy
timeFrame: predose; after the full initial dose of the antibiotic has infused, at 5min, 15min, 30min, 2-3hr, 4-6hr, immediately prior to the next dose of drug, and at DELIVERY
Secondary outcomes:
measure: Profile of Neonatal Metabolism of Ampicillin and Gentamicin That Crosses the Placental Barrier
timeFrame: At delivery/upon cutting of umbilical cord
measure: PD Modeling of Peripartum Patients Receiving Ampicillin and/or Gentamicin
timeFrame: predose; while dosing; post dose
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucille Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Brendan Carvalho, MBBCh
role: STUDY_DIRECTOR
affiliation: Stanford University
name: David Drover, MD
role: STUDY_DIRECTOR
References: