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Pharmacokinetics and Safety of Ertapenem in the Postpartum Period

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01587495
Recruitment Status : Terminated (study terminated due to low subject accrual)
First Posted : April 30, 2012
Last Update Posted : May 20, 2015
Information provided by (Responsible Party):
Daniel Benjamin, Duke University

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.

Condition or disease Intervention/treatment Phase
Endometritis Drug: Ertapenem Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Safety of Ertapenem in the Postpartum Period
Study Start Date : March 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arm Intervention/treatment
Experimental: Ertapenem
Women diagnosed with postpartum endometritis
Drug: Ertapenem
Ertapenem will be administered by intravenous infusion per the FDA approved standard of care (1 gram q24 hours). as follows:
Other Name: Invanz

Primary Outcome Measures :
  1. Measure fraction of total and unbound Ertapenem. [ Time Frame: 2 years ]
    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 :
  1. Correlation between plasma drug concentrations and safety outcomes [ Time Frame: 2 years ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01587495

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United States, North Carolina
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Daniel Benjamin
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Principal Investigator: Geeta Swamy, MD Duke University

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Responsible Party: Daniel Benjamin, Professor, Duke University Identifier: NCT01587495    
Other Study ID Numbers: Pro00030565
First Posted: April 30, 2012    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Anti-Bacterial Agents
Anti-Infective Agents