Ignite Creation Date:
2024-05-06 @ 12:05 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01489124
Status:
COMPLETED
Last Update Posted:
2011-12-09
First Post:
2011-11-23
Brief Title:
The Population Pharmacokinetics of Imipenem in Patients With Ventilator-associated Pneumonia
Sponsor:
Sutep Jaruratanasirikul
Organization:
Prince of Songkla University
Study Overview
Official Title:
The Population Pharmacokinetics of Imipenem in Patients With Ventilator-associated Pneumonia
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is prospective randomized and crossover design to assess the pharmacokinetic and pharmacodynamics of three regimen
05-hr infusion of imipenem 05 g every 6 hrs
2-hr infusion of imipenem 05 g every 6 hrs
2-hr infusion of imipenem 1 g every 6 hrs
Clinical and laboratory data such as AgeSex Body weight CBC Electrolyte Vital signs APACHE II score BUN Cr Sample and Blood culture will be collected
Nine patients will be enrolled in this study After completion of the imipenem therapy for 3 days in this study all patients will receive other sensitive antibiotics to eradicate their bacterial infections
Blood samples approximately 3 ml will be obtained by direct venepuncture at the following time 0 05 1 2 3 4 5 and 6 after 4th dose of imipenem
Concentration of imipenem in plasma will be measured by HPLC method Then the data will be simulated in Monte Carlo technique Computer model to get PKPD index 40TMIC and reported to PTA Probability Target Attainment and CFR Cumulative Faction Response
05-hr infusion of imipenem 05 g every 6 hrs
2-hr infusion of imipenem 05 g every 6 hrs
2-hr infusion of imipenem 1 g every 6 hrs
Clinical and laboratory data such as AgeSex Body weight CBC Electrolyte Vital signs APACHE II score BUN Cr Sample and Blood culture will be collected
Nine patients will be enrolled in this study After completion of the imipenem therapy for 3 days in this study all patients will receive other sensitive antibiotics to eradicate their bacterial infections
Blood samples approximately 3 ml will be obtained by direct venepuncture at the following time 0 05 1 2 3 4 5 and 6 after 4th dose of imipenem
Concentration of imipenem in plasma will be measured by HPLC method Then the data will be simulated in Monte Carlo technique Computer model to get PKPD index 40TMIC and reported to PTA Probability Target Attainment and CFR Cumulative Faction Response
Detailed Description:
Introduction Ventilator-associated pneumonia VAP is a common cause of nosocomial infection with a high mortality rate In the current era of increasing highly resistant pathogens in nosocomial infections the empirical treatment of these organisms is becoming more difficult and only a few novel antimicrobial agents are currently in development with activity against these highly resistant Gram negative bacilli infections Imipenem a carbapenem antibiotic is a β-lactam antibacterial agent with a broad spectrum of activity against both Gram positive and Gram negative bacteria This agent is still one of the most commonly used antibiotics for empirical therapy of highly resistant nosocomial infections in VAP In common with other β-lactams imipenem exhibits primarily time dependent killing and increasing the concentration of this agent does not necessarily increase the rate and extent of bacterial killing Therefore the time that concentrations in serum are above the MIC TMIC is the pharmacokineticpharmacodynamic PKPD index that correlates with efficacy Pharmacodynamic analysis can be applied to imipenem dosages to increase the likelihood of optimal exposure and achieve good clinical responses in patients with VAP Previous studies we performed found that a 2 h infusion of carbapenem antibiotics gave greater values for TMIC than a 05 h infusion Therefore in an attempt to improve the efficacy of the present β-lactam antimicrobial agents such as imipenem a prolonged infusion would be the appropriate mode for administration to promote the maximal bactericidal effectPK changes have been found for several hydrophilic antimicrobial agents in critically ill patients Drug dispositions are altered in this patient population when compared with healthy subjects leading to fluctuations of plasma concentrations Therefore the aim of this study was to assess the PD of imipenem in VAP patients comparing administration by 05 h infusion or 2 h infusion
Objectives To assess the pharmacokinetic and pharmacodynamics of three regimen as below
i 05-hr infusion of imipenem 05 g every 6 hrs ii 2-hr infusion of imipenem 05 g every 6 hrs iii 2-hr infusion of imipenem 1 g every 6 hrs
Drug preparationImipenem will be reconstituted with 100 ml saline solution according to the manufacturers guidelines
Study design This is prospective randomized and crossover design to assess
Each patients will receive doripenem in 3 regimens consecutively
i 05-hr infusion of imipenem 05 g every 6 hrs ii 2-hr infusion of imipenem 05 g every 6 hrs iii 2-hr infusion of imipenem 1 g every 6 hrs
Nine patients will be enrolled in this study After completion of the imipenem therapy for 3 days in this study all patients will receive other sensitive antibiotics to eradicate their bacterial infections
Sample collections Blood samples approximately 3 ml will be obtained by direct venepuncture at the following time 0 05 1 2 3 4 5 and 6 after 4th dose of imipenem All blood samples will be allowed to clot and then centrifuged at 2000g The serum obtained will be stored at-80C until analysis
Imipenem assays by HPLC method e performed at Department of Medicine Faculty of Medicine
Clinical and laboratory data such as AgeSex Body weight CBC Electrolyte Vital signs APACHE II score BUN Cr Sample and Blood culture will be collected
Duration of study Patients will receive imipenem for 3 days
Pharmacokinetic and pharmacodynamic analysis Concentration of imipenem in plasma will be measured by HPLC method and simulated in Monte Carlo technique Computer model to get PKPD index 40TMIC and reported to PTA Probability Target Attainment and CFR Cumulative Faction Response
Sample Size Nine patients with VAP will be enrolled in this study
Objectives To assess the pharmacokinetic and pharmacodynamics of three regimen as below
i 05-hr infusion of imipenem 05 g every 6 hrs ii 2-hr infusion of imipenem 05 g every 6 hrs iii 2-hr infusion of imipenem 1 g every 6 hrs
Drug preparationImipenem will be reconstituted with 100 ml saline solution according to the manufacturers guidelines
Study design This is prospective randomized and crossover design to assess
Each patients will receive doripenem in 3 regimens consecutively
i 05-hr infusion of imipenem 05 g every 6 hrs ii 2-hr infusion of imipenem 05 g every 6 hrs iii 2-hr infusion of imipenem 1 g every 6 hrs
Nine patients will be enrolled in this study After completion of the imipenem therapy for 3 days in this study all patients will receive other sensitive antibiotics to eradicate their bacterial infections
Sample collections Blood samples approximately 3 ml will be obtained by direct venepuncture at the following time 0 05 1 2 3 4 5 and 6 after 4th dose of imipenem All blood samples will be allowed to clot and then centrifuged at 2000g The serum obtained will be stored at-80C until analysis
Imipenem assays by HPLC method e performed at Department of Medicine Faculty of Medicine
Clinical and laboratory data such as AgeSex Body weight CBC Electrolyte Vital signs APACHE II score BUN Cr Sample and Blood culture will be collected
Duration of study Patients will receive imipenem for 3 days
Pharmacokinetic and pharmacodynamic analysis Concentration of imipenem in plasma will be measured by HPLC method and simulated in Monte Carlo technique Computer model to get PKPD index 40TMIC and reported to PTA Probability Target Attainment and CFR Cumulative Faction Response
Sample Size Nine patients with VAP will be enrolled in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None