The Pharmacodynamics of Meropenem in Patient With Ventilator-associated Pneumonia

Summary

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)

Conditions

• Ventilator-Associated Pneumonia

Interventions

DRUG

Meropenem

1 g in 100 ml of normal saline solution and administered via bolus injection Blood samples (approximately 5 ml)will be obtained by direct venepuncture at the following time: before (time zero) and 10 and 30 min and 1, 1.5, 2, 2.5, 3.5, 4, 4.5, 5, 6, and 8 hh after 3rd dose of meropenem

DRUG

Meropenem

1 g in 100 ml of normal saline solution and administered via an infusion pump at a constant flow rate over 3 h every 8 h. Blood samples (approximately 5 ml)will be obtained by direct venepuncture at the following time: 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 3rd dose of meropenem.

DRUG

Meropenem

2 g in 100 ml of normal saline solution and administered via an infusion pump at a constant flow rate over 3 h every 8 h. Blood samples (approximately 5 ml)will be obtained by direct venepuncture at the following time: 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 3rd dose of meropenem.

Sponsors & Collaborators

• Prince of Songkla University

  collaborator OTHER

• Sutep Jaruratanasirikul

  lead OTHER

Principal Investigators

• Sutep Jaruratanasirikul, MD · Prince of Songkla University

Study Design

Allocation

RANDOMIZED

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-01-31

Primary Completion

2005-01-31

Completion

2005-01-31

Countries

• Thailand

Study Locations