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

NCT ID: NCT02427932

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-01-31

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.

Conditions

Drug Metabolism During Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pregnant/Ampicillin

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

Ampicillin

Intervention Type: 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

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

Ampicillin

Intervention Type: 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

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

Ampicillin and Gentamicin

Intervention Type: 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

Non-Pregnant/Gentamicin

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

Gentamicin

Intervention Type: DRUG

Prescribed to non-pregnant participants

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Gentamicin

Prescribed to non-pregnant participants

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

David Drover, MD

UNKNOWN

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Brendan Carvalho

MBBCh, FRCA, MDCH, Associate Professor, Dept. of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brendan Carvalho, MBBCh

Role: STUDY_DIRECTOR

Stanford University

David Drover, MD

Role: STUDY_DIRECTOR

Stanford University

Locations

Lucille Packard Children's Hospital

Palo Alto, California, United States

Countries

United States

Other Identifiers

29664

Identifier Type: -

Identifier Source: org_study_id