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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01148771
Recruitment Status : Completed
First Posted : June 22, 2010
Results First Posted : May 11, 2012
Last Update Posted : May 11, 2012
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: ertapenem Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Comparative Pharmacokinetics, Safety, and Pharmacodynamics of Ertapenem 1 Gram Daily Administered as an IV Bolus Versus Standard 30 Minute Infusion to Healthy Adult Volunteers
Study Start Date : August 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ertapenem 1 gram intravenous (IV) 5 minute bolus
Participants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 5 minute IV bolus.
Drug: ertapenem
1 gram IV bolus every 24 hours (q24h) for 3 days

Active Comparator: Ertapenem 1 gram IV 30 minute infusion
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).
Drug: ertapenem
1 gram 30 minute infusion q24h for 3 days

Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose) [ Time Frame: 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.

  2. Area Under the Curve From 48 to 72 Hours [AUC(48-72)] [ Time Frame: 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 :
  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 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.

  2. Probability of Target Attainment (PTA) [ Time Frame: 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01148771

United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Sponsors and Collaborators
Hartford Hospital
Merck Sharp & Dohme Corp.
Principal Investigator: Josepth L Kuti, PharmD Hartford Hospital
Study Director: Dora E Wiskirchen, PharmD Hartford Hospital

Responsible Party: Hartford Hospital Identifier: NCT01148771     History of Changes
Other Study ID Numbers: KUTI003194HE
IISP ID#37935 ( Other Grant/Funding Number: Merck )
First Posted: June 22, 2010    Key Record Dates
Results First Posted: May 11, 2012
Last Update Posted: May 11, 2012
Last Verified: April 2012

Keywords provided by Hartford Hospital:

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents