Pharmacokinetics and Safety of Ertapenem in the Postpartum Period

NCT01587495 | Terminated Phase 1

• 1 other identifier: Pro00030565
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometritis

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• Correlation between plasma drug concentrations and safety outcomes

  2 years

Study Arms (1)

Ertapenem

EXPERIMENTAL

Women diagnosed with postpartum endometritis

Drug: Ertapenem

Interventions

Ertapenem DRUG

Ertapenem will be administered by intravenous infusion per the FDA approved standard of care (1 gram q24 hours). as follows:

Also known as: Invanz

Ertapenem

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Daniel Benjamin: lead

Study Sites (1)

DUMC

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Endometritis

Interventions

Ertapenem

Condition Hierarchy (Ancestors)

Pelvic Inflammatory Disease; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Uterine Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Geeta Swamy, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: April 30, 2012
• Study Start: March 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

US (1)