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

NCT02427932 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2017-05-10

No results posted yet for this study

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

Interventions

DRUG

Ampicillin

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

DRUG

Ampicillin and Gentamicin

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

DRUG

Gentamicin

Prescribed to non-pregnant participants

Sponsors & Collaborators

Principal Investigators

  • Brendan Carvalho, MBBCh · Stanford University

  • David Drover, MD · Stanford University

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02427932 on ClinicalTrials.gov