Pharmacokinetics and Safety of Ertapenem in the Postpartum Period
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 Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pharmacokinetics and Safety of Ertapenem in the Postpartum Period|
- Measure fraction of total and unbound Ertapenem. [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
- Correlation between plasma drug concentrations and safety outcomes [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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 Name: Invanz
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.
|Contact: Avinash Patil Patil, MD||919-681-5220|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Contact: Avi Patil, MD|
|Principal Investigator: Geeta Swamy, MD|
|Principal Investigator:||Geeta Swamy, MD||Duke University|