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Pharmacokinetics and Safety of Ertapenem in the Postpartum Period

Primary Purpose

Endometritis

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ertapenem
Sponsored by
Daniel Benjamin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older at the time of enrollment.
  • Postpartum period < 42 days at the time of enrollment.
  • Sufficient venous access to permit administration of study medication.
  • 2 clinical signs of postpartum endometritis:

    • Oral body temperature of > 101oF at any time, or a temperature of 100.4 on two occasions 6 hours apart.
    • Maternal tachycardia that parallels the temperature.
    • Uterine tenderness
    • Purulent vaginal discharge
  • Findings of advanced endometritis: dynamic ileus, pelvic peritonitis, pelvic abscess, bowel obstruction, necrosis of the lower uterine segment.

Exclusion Criteria:

  • History of previous hypersensitivity reactions to beta lactams.
  • Receiving valproic acid or divalproex sodium.
  • Creatinine clearance < 30 mL/min as calculated by the Cockroft-Gault equation.
  • Subject with a medical condition that, in the opinion of the investigator, would interfere with the pharmacokinetic evaluation of the medication, place the subject at an unacceptable risk of injury, or render the subject unable to meet the requirements of the protocol.
  • Previous participation in the study.
  • Exposure to ertapenem in the week prior to the study

Sites / Locations

  • DUMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ertapenem

Arm Description

Women diagnosed with postpartum endometritis

Outcomes

Primary Outcome Measures

Measure fraction of total and unbound Ertapenem.
The fraction of unbound drug will be calculated using total and unbound drug concentrations. The appropriate non-compartmental pharmacokinetic parameters will be computed, including AUC24, AUCss, Cmax, CL, Vss, t1/2. PK parameters will be summarized by study cohort and compared using standard statistical methodology.

Secondary Outcome Measures

Correlation between plasma drug concentrations and safety outcomes
Adverse events (AE) thought to be related (definitely and probably) to study drug and all serious adverse events (SAE) will be recorded. The investigator will provide date of onset and resolution, intensity, frequency, action(s) taken, changes in study drug dosing and outcome.The safety review will include all SAEs, all AEs thought to be possibly or probably related to the study drug, and all patients who discontinued participation in the study early.

Full Information

First Posted
April 5, 2012
Last Updated
May 19, 2015
Sponsor
Daniel Benjamin
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1. Study Identification

Unique Protocol Identification Number
NCT01587495
Brief Title
Pharmacokinetics and Safety of Ertapenem in the Postpartum Period
Official Title
Pharmacokinetics and Safety of Ertapenem in the Postpartum Period
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
study terminated due to low subject accrual
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel Benjamin

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators are doing this study to learn more about the dosing and safety of ertapenem in women with suspected serious infections less than 42 days from the delivery of their infant.
Detailed Description
Ertapenem has received FDA approval for the indication of acute pelvic infection, though there is no pharmacokinetic data to guide dosing of ertapenem in postpartum women. The physiologic changes of the postpartum period make it likely that this special population requires dosing modification to achieve desired therapeutic targets. The objective of this study is to obtain a detailed knowledge of the pharmacokinetics of ertapenem during the postpartum period that will result in improved guidelines on maternal dosing and neonatal exposure. This is a prospective, open-label, single center, pharmacokinetic study of ertapenem in women diagnosed with postpartum endometritis. Subjects will include up to 24 women receiving treatment for a diagnosis of postpartum endometritis with ertapenem in the Duke University Hospital Labor & Delivery Unit. Each patient will participate in the study for approximately 7 days, though the total study duration is expected to be approximately 12 months. Descriptive statistics for the subjects will be calculated. The appropriate non-compartmental pharmacokinetic parameters will be computed, including AUC24, AUCss, Cmax, CL, Vss, t1/2. All subjects who receive one dose of study drug will be followed for safety, with planned internal review of safety data following the completion of 12 patients. Nursing infants of study subjects will also be followed for safety due to the potential for exposure to study drug through breastmilk.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ertapenem
Arm Type
Experimental
Arm Description
Women diagnosed with postpartum endometritis
Intervention Type
Drug
Intervention Name(s)
Ertapenem
Other Intervention Name(s)
Invanz
Intervention Description
Ertapenem will be administered by intravenous infusion per the FDA approved standard of care (1 gram q24 hours). as follows:
Primary Outcome Measure Information:
Title
Measure fraction of total and unbound Ertapenem.
Description
The fraction of unbound drug will be calculated using total and unbound drug concentrations. The appropriate non-compartmental pharmacokinetic parameters will be computed, including AUC24, AUCss, Cmax, CL, Vss, t1/2. PK parameters will be summarized by study cohort and compared using standard statistical methodology.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Correlation between plasma drug concentrations and safety outcomes
Description
Adverse events (AE) thought to be related (definitely and probably) to study drug and all serious adverse events (SAE) will be recorded. The investigator will provide date of onset and resolution, intensity, frequency, action(s) taken, changes in study drug dosing and outcome.The safety review will include all SAEs, all AEs thought to be possibly or probably related to the study drug, and all patients who discontinued participation in the study early.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older at the time of enrollment. Postpartum period < 42 days at the time of enrollment. Sufficient venous access to permit administration of study medication. 2 clinical signs of postpartum endometritis: Oral body temperature of > 101oF at any time, or a temperature of 100.4 on two occasions 6 hours apart. Maternal tachycardia that parallels the temperature. Uterine tenderness Purulent vaginal discharge Findings of advanced endometritis: dynamic ileus, pelvic peritonitis, pelvic abscess, bowel obstruction, necrosis of the lower uterine segment. Exclusion Criteria: History of previous hypersensitivity reactions to beta lactams. Receiving valproic acid or divalproex sodium. Creatinine clearance < 30 mL/min as calculated by the Cockroft-Gault equation. Subject with a medical condition that, in the opinion of the investigator, would interfere with the pharmacokinetic evaluation of the medication, place the subject at an unacceptable risk of injury, or render the subject unable to meet the requirements of the protocol. Previous participation in the study. Exposure to ertapenem in the week prior to the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geeta Swamy, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
DUMC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Pharmacokinetics and Safety of Ertapenem in the Postpartum Period

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