Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients

NCT01027897 | Completed Phase 4 Results

• 2 other identifiers: IRB00016181aDORICPK4003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study hypothesis is to measure how the drug doripenem is cleared from the body of critically ill trauma patients. The investigators will measure blood drug concentrations and calculate how much the drug distributes in the body and how fast it is removed from the body. There is little information on how drugs are cleared in critically ill patients and the wrong dose of a drug could make it ineffective. The investigators will use this information to predict the most reasonable dose to treat infections effectively in these patients.

Conditions

Sepsis

Keywords

Pharmacokinetics; Pharmacodynamics; Doripenem; Trauma; sepsis; Trauma patients with sepsis

Outcome Measures

Primary Outcomes (3)

• Volume of Distribution (Vd)

  The Volume of distribution is the calculated volume that the given amount of drug is uniformly distributed in the body to achieve a particular concentration

  After 3rd dose of study medication

• Clearance (CL)

  Clearance is the volume of drug removed from the body per unit of time (hrs).

  After 3rd dose of study medication

• Elimination Constant (ke)

  The elimination rate constant of a drug from the central compartment

  after 3rd dose of study drug

Study Arms (1)

Doripenem group

EXPERIMENTAL

Patients will receive doripenem for the treatment of their infection

Drug: Doripenem

Interventions

Doripenem DRUG

Doripenem 1 gm administered over 4 hours X 3 doses

Doripenem group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are 18 years of age or older
• Admitted to Emory surgical intensive care unit (ICU) service
• Have a diagnosis of sepsis that requires empiric antimicrobial therapy
• Obtained written informed consent from the patient or a first-degree relative if the patient is unable to give informed consent due to his/her medical condition prior to initiation of any study procedure

You may not qualify if:

• Surgical ICU length of stay less than 24 hours
• Acute or chronic renal dysfunction (urine output less than 0.5 mL/kg/hr or calculated creatinine clearance of less than 50 mL/min)
• Pregnancy
• Known allergy to beta-lactam antibiotics
• Non-English-speaking patients

Sponsors & Collaborators

• Emory University: lead
• Ortho-McNeil Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Sepsis; Wounds and Injuries

Interventions

Doripenem

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Prasad Abraham
• Organization: Grady Health System

pabraham@gmh.edu

404-616-3246

Study Officials

• Jeffrey Salomone, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2009
• First Posted: December 9, 2009
• Study Start: April 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 27, 2014
• Results First Posted: September 25, 2012

Record last verified: 2013-12

Locations

US (1)