Pharmacokinetics (PK) of Ertapenem Intravenous (IV) Bolus Versus Standard Infusion

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: ertapenem

• Registration Number: NCT01148771
• Lead Sponsor: Hartford Hospital

Brief Summary

The purpose of this study is to characterize and compare the concentration-time profiles and multiple dose pharmacokinetics of a 5 minute intravenous (IV) bolus of ertapenem 1 gram daily versus the standard 30 minute infusion in healthy volunteers. Safety and tolerability and pharmacodynamic target attainment using Monte Carlo simulation will also be assessed and compared.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-18
• Study First Submitted QC: 2010-06-21
• Study First Posted: 2010-06-22
• Study Start: 2010-08
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2012-03-15
• Status Verified: 2012-04
• Results First Submitted QC: 2012-04-13
• Last Update Submitted: 2012-04-13
• Results First Posted: 2012-05-11
• Last Update Posted: 2012-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Healthy adults (18 years of age or older)

Exclusion Criteria

• Ertapenem or other beta-lactam allergy
• Pregnant or breast feeding females
• Body Mass Index (BMI) greater than or equal to 30
• Abnormal lab values at baseline
• Hypertension
• Significant medical abnormality
• Regular alcohol consumption
• Significant nicotine use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ertapenem 1 gram intravenous (IV) 5 minute bolus	ertapenem	Participants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 5 minute IV bolus.
Ertapenem 1 gram IV 30 minute infusion	ertapenem	Participants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 30 minute infusion (i.e., the standard dose).

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose)	5 or 30 minutes post start of infusion on Day 3	Cmax is measured at 5 minutes after the beginning of the infusion for the 5 minute IV bolus dosage regimen and at 30 minutes after the beginning of the infusion for the 30 minute infusion dosage regimen.
Area Under the Curve From 48 to 72 Hours [AUC(48-72)]	0-24 hours after 3rd ertapenem dose	AUC(48-72) is the 24 hour area under the concentration versus time curve after the 3rd dose of ertapenem, which is selected to measure approximate AUC at steady-state.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	3 days	The following laboratory assessments will be make before and after participation in the study to determine if objective changes occurred: blood pressure, pulse rate, temperature, complete blood count with differential, platelet count, blood urea nitrogen, serum creatinine, liver function panel \[aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase\], total bilirubin, and urinalysis with microscopy. Monitoring of other pathologic or unintended changes in structure (signs),or function (symptoms) of the body associated with participation in the study will occur.
Probability of Target Attainment (PTA)	Simulated Steady-State Exposure	After simulating 5000 patients receiving each dosing regimen, the probability of achieving free drug concentrations above an MIC of 0.25 mcg/mL and 0.5mcg/mL for at least 40% of the dosing interval (40% fT\>MIC) is calculated at each MIC dilution.

Trial Locations

Locations (1)

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States