Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01587495
Study type Interventional
Source Duke University
Contact
Status Terminated
Phase Phase 1
Start date March 2012
Completion date January 2014

See also
  Status Clinical Trial Phase
Recruiting NCT05049395 - HFNO Reducing the Incidence of Hypoxia for Hysteroscopy Sedated With Propofol N/A
Terminated NCT00386477 - Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial N/A
Terminated NCT04163679 - Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections N/A
Recruiting NCT03960970 - Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries Phase 2
Completed NCT03459599 - Antibiotic Prophylaxis in Ragged Placental Membranes N/A
Completed NCT01762098 - Chronic Endometritis in Patients With Recurrent Miscarriages or Repeated Implantation Failures in In-vitro Fertilization N/A
Withdrawn NCT01721616 - Comparison Study of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis Phase 4
Completed NCT01464840 - The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery N/A
Completed NCT01235546 - Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection N/A
Recruiting NCT04307069 - Management of Prelabor Rupture of the Membranes at Term N/A
Completed NCT03442218 - Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section N/A
Not yet recruiting NCT01945450 - Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth: a Randomized Controlled Trial N/A
Completed NCT00547170 - Doxycycline Prophylaxis at Vacuum Aspiration Trial Phase 4
Completed NCT00501033 - A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter N/A
Completed NCT00500019 - Uterine Flora During Elective and Urgent Cesarean Sections N/A
Completed NCT00330278 - Timing of Prophylactic Antibiotics for Cesarean Sections N/A
Completed NCT00603603 - Controlled Clinical Trial of Supplemental Oxygen for the Prevention of Post-Cesarean Infectious Morbidity N/A
Completed NCT00858832 - Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine N/A
Recruiting NCT04197167 - Mid-Infrared Spectroscopy as a Real Time Diagnostic Tool for Chronic Endometritis N/A
Completed NCT02402907 - STRIPES Study: Study To Reduce Infection Post cEsarean Section N/A