- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01587495
Pharmacokinetics and Safety of Ertapenem in the Postpartum Period
May 19, 2015 updated by: Daniel Benjamin
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- DUMC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ertapenem
Women diagnosed with postpartum endometritis
|
Ertapenem will be administered by intravenous infusion per the FDA approved standard of care (1 gram q24 hours).
as follows:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
April 5, 2012
First Submitted That Met QC Criteria
April 26, 2012
First Posted (Estimate)
April 30, 2012
Study Record Updates
Last Update Posted (Estimate)
May 20, 2015
Last Update Submitted That Met QC Criteria
May 19, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00030565
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Endometritis
-
Erzincan Military HospitalCompletedPostpartum EndometritisTurkey
-
Duke UniversityUniversity of Illinois at ChicagoCompleted
-
Fu Xing Hospital, Capital Medical UniversityCompletedChronic EndometritisChina
-
Genesis Athens ClinicCompletedChronic EndometritisGreece
-
Sarawak General HospitalUniversity Malaysia SarawakCompletedEndometritis | Endometritis Postpartum | Membranes; Retained
-
Genesis Athens ClinicNational and Kapodistrian University of AthensRecruitingChronic EndometritisGreece
-
IgenomixUniversity of Valencia; INCLIVATerminated
-
Cairo UniversityCompletedAzithromycin | Postpartum Endometritis | Meconium StainedEgypt
-
Universitair Ziekenhuis BrusselNot yet recruitingSubfertility | Endometritis; ChronicBelgium
-
Scientific Center for Family Health and Human Reproduction...Completed
Clinical Trials on Ertapenem
-
University Medical Center GroningenCompleted
-
University of MichiganCompletedAcute Kidney FailureUnited States
-
Catholic University of the Sacred HeartMerck Sharp & Dohme LLCUnknown
-
Merck Sharp & Dohme LLCCompleted
-
Hartford HospitalMerck Sharp & Dohme LLCCompletedHealthyUnited States
-
Klinikum Hanover-Siloah HospitalUnknownAcute Disease | Diverticulitis, ColonicGermany
-
Prince of Songkla UniversityUnknownPatients With Urosepis and Received Ertapenem for TreatmentThailand
-
Albany College of Pharmacy and Health SciencesMerck Sharp & Dohme LLCCompletedEnd Stage Renal Disease | Continuous Ambulatory Peritoneal DialysisUnited States
-
Merck Sharp & Dohme LLCCompleted