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

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ClinicalTrials.gov Identifier: NCT02427932
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : May 10, 2017
Sponsor:
Collaborator:
David Drover, MD
Information provided by (Responsible Party):
Brendan Carvalho, Stanford University

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.

Condition or disease Intervention/treatment
Drug Metabolism During Pregnancy Drug: Ampicillin Drug: Ampicillin and Gentamicin Drug: Gentamicin

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.


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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PK and PD Modeling of Ampicillin and Gentamicin in Peripartum Patients
Actual Study Start Date : May 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pregnant/Ampicillin
pregnant participants who will receive Ampicillin for conditions such as Group B Streptococcus
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

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

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
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
Drug: Gentamicin
Prescribed to non-pregnant participants




Primary Outcome Measures :
  1. Pharmacokinetic Profiling to Measure Maternal Metabolism of Ampicillin and/or Gentamicin in Pregnancy [ Time Frame: 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 ]
    blood samples will be taken at the above timepoints; data analysis of all specimens will begin approx. 12-15 months from start of study


Secondary Outcome Measures :
  1. Profile of Neonatal Metabolism of Ampicillin and Gentamicin That Crosses the Placental Barrier [ Time Frame: At delivery/upon cutting of umbilical cord ]
    blood samples to be drawn at the above timepoint; data analysis of all specimens will begin approx. 12-15 months from start of study

  2. PD Modeling of Peripartum Patients Receiving Ampicillin and/or Gentamicin [ Time Frame: predose; while dosing; post dose ]
    subject will be observed for adverse events related to drug administration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women receiving ampicillin or gentamicin
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427932


Locations
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United States, California
Lucille Packard Children's Hospital
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
David Drover, MD
Investigators
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Study Director: Brendan Carvalho, MBBCh Stanford University
Study Director: David Drover, MD Stanford University

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Responsible Party: Brendan Carvalho, MBBCh, FRCA, MDCH, Associate Professor, Dept. of Anesthesia, Stanford University
ClinicalTrials.gov Identifier: NCT02427932     History of Changes
Other Study ID Numbers: 29664
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017

Keywords provided by Brendan Carvalho, Stanford University:
Pharmacokinetics (PK)
Pharmacodynamics (PD)

Additional relevant MeSH terms:
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Gentamicins
Ampicillin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action