Pharmacokinetic (PK) and Pharmacodynamic (PD) Modeling of Ampicillin and Gentamicin in Peripartum Patients

NCT02427932 | Completed

• 1 other identifier: 29664
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Metabolism During Pregnancy

Keywords

Pharmacokinetics (PK); Pharmacodynamics (PD)

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic Profiling to Measure Maternal Metabolism of Ampicillin and/or Gentamicin in Pregnancy

  blood samples will be taken at the above timepoints; data analysis of all specimens will begin approx. 12-15 months from start of study

  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 (2)

• Profile of Neonatal Metabolism of Ampicillin and Gentamicin That Crosses the Placental Barrier

  At delivery/upon cutting of umbilical cord

• PD Modeling of Peripartum Patients Receiving Ampicillin and/or Gentamicin

  predose; while dosing; post dose

Study Arms (4)

Pregnant/Ampicillin

pregnant participants who will receive Ampicillin for conditions such as Group B Streptococcus

Drug: Ampicillin

Non-pregnant/Ampicillin

non-pregnant participants who will receive Ampicillin for a qualifying hospital admission

Drug: Ampicillin

Pregnant and Non-pregnant/Ampicillin and Gentamicin

pregnant participants who will receive Ampicillin and Gentamicin for conditions such as chorioamnionitis; non-pregnant participants who will receive Ampicillin and Gentamicin for a qualifying hospital admission

Drug: Ampicillin and Gentamicin

Non-Pregnant/Gentamicin

non-pregnant participants who will receive Gentamicin for a qualifying hospital admission

Drug: Gentamicin

Interventions

Ampicillin DRUG

Pregnant participants will receive Ampicillin 2g IV loading dose followed by 1g IV every 4 hrs until delivery for Group B Strep prophylaxis; non-pregnant participants will receive Ampicillin for qualifying diagnosis

Non-pregnant/Ampicillin; Pregnant/Ampicillin

Ampicillin and Gentamicin DRUG

Pregnant participants will receive Ampicillin 2g IV every 6hrs along with Gentamicin 5mg/kg IV every 24 hrs for chorioamnionitis; non-pregnant participants will receive for qualifying diagnosis

Pregnant and Non-pregnant/Ampicillin and Gentamicin

Gentamicin DRUG

Prescribed to non-pregnant participants

Non-Pregnant/Gentamicin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women receiving ampicillin or gentamicin

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• David Drover, MD: collaborator

Study Sites (1)

Lucille Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

MeSH Terms

Interventions

Ampicillin; Gentamicins

Intervention Hierarchy (Ancestors)

Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Brendan Carvalho, MBBCh

  Stanford University

  STUDY DIRECTOR

• David Drover, MD

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBCh, FRCA, MDCH, Associate Professor, Dept. of Anesthesia

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 28, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: May 10, 2017

Record last verified: 2017-05

Locations

US (1)