Ventilator-Associated Pneumonia Clinical Trial
Official title:
The Pharmacodynamics of Meropenem in Patient With Ventilator-associated Pneumonia
The study was a randomized three-way crossover study. Each subject received meropenem in
three regimens at room temperature consecutively: (i) bolus injection of 1 g of meropenem
over 10 min every 8 h for 24 h, (ii) 3-h infusion of 1 g of meropenem via an infusion pump
at a constant flow rate every 8 h for 24 h, and(iii) 3-h infusion of 2 g of meropenem via an
infusion pump at a constant flow rate every 8 h for 24 h.
Clinical and laboratory data such as Age,Sex, Body weight, Electrolyte, Vital signs, APACHE
II score, BUN, Cr, Blood culture will be collected.
Nine patients will be enrolled in this study. After completion of the meropenem therapy for
3 days in this study, all patients will receive other sensitive antibiotics to eradicate
their bacterial infections.
Meropenem pharmacokinetic studies were carried out during administration of the third dose
of each regimen (16 to 24 h after the start of each regimen). Blood samples (approximately 5
ml) were obtained by direct venipuncture at the following times: before (time zero) and 10
and 30 min and
1, 1.5, 2, 2.5, 3.5, 4, 4.5, 5, 6, and 8 h after the third dose of each regimen.
The concentrations of meropenem were determined by reverse-phase high-performance liquid
chromatography.
Concentration of meropenem in plasma will be simulated in Monte Carlo technique (Computer
model) to get PK/PD index (40%T>MIC) and reported to % PTA(Probability Target Attainment)
and %CFR (Cumulative Faction Response)
Introduction:
Meropenem is a carbapenem antibacterial agent with a broad spectrum of activity against
several pathogens. In common with other -lactams, the main pharmacokinetic/pharmacodynamic
parameter that correlates with the therapeutic efficacy is the T>MIC, and administration by
continuous infusion is the preferred route to maximize this parameter. However, in tropical
countries the stability of meropenem is an important consideration when continuous infusion
is to be used.
Objective:
The aim of this study was to demonstrate the T>MIC of meropenem when administered by a 3-h
infusion compared with that when administered by bolus injection.
Study design:
The study was conducted with nine patients with ventilator-associated pneumonia. Each
subject received meropenem in three regimens consecutively: (i) bolus injection of 1 g every
8 h for 24 h; (ii) 3-h infusion of 1 g every 8 h for 24 h; and (iii) 3-h infusion of 2 g
every 8 h for 24 h.
Sample collections:
Meropenem pharmacokinetic studies were carried out during administration of the third dose
of each regimen (16 to 24 h after the start of each regimen). Blood samples (approximately 5
ml) were obtained by direct venipuncture at the following times: before (time zero) and 10
and 30 min and 1, 1.5, 2, 2.5, 3.5, 4, 4.5, 5, 6, and 8 h after the third dose of each
regimen.
Meropenem assay:
The concentrations of meropenem were determined by reverse-phase high-performance liquid
chromatography. Cefepime (100 mcg/ml) was used as the internal standard, and the samples
were extracted by the method of Ozkan et al.
Clinical data and pathogens collection:
1. Initial patient demographic data (age, sex, weight, diagnosis, APACHE II scores) will
be collected upon enrollment in the study.
2. The Gram negative bacilli isolated from sputum in 9 patients will be collected and the
MIC of the meropenem for pathogens will be determined by E tests upon enrollment in the
study.
Duration of study:
Patients will receive meropenem for 3 days
Pharmacokinetic and pharmacodynamic analysis:
Concentration of meropenem in plasma will be simulated in Monte Carlo technique (Computer
model) to get PK/PD index (40%T>MIC) and reported to % PTA (Probability Target Attainment)
and %CFR (Cumulative Faction Response) Sample Size: Nine patients with VAP will be enrolled
in this study.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label
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