The Population Pharmacokinetics of Imipenem in Patients With Ventilator-associated Pneumonia

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is prospective, randomized and crossover design to assess the pharmacokinetic and pharmacodynamics of three regimen.

• 0.5-hr infusion of imipenem 0.5 g every 6 hrs

• 2-hr infusion of imipenem 0.5 g every 6 hrs

• 2-hr infusion of imipenem 1 g every 6 hrs

Clinical and laboratory data such as Age,Sex, 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, 0.5, 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 PK/PD index (40%T>MIC) and reported to % PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sutep Jaruratanasirikul
• Collaborator: Prince of Songkla University
• Treatments: Imipenem

Criteria

Inclusion Criteria:

• Patients aged ≥ 18 years

• Patients are intubated and receiving mechanical ventilation.

• Patients have clinical suspicion of VAP with Gram negative bacilli infections, defined by a new and persistent infiltrate on chest radiography associated with at least one of the following: purulent tracheal secretions, temperature of 38.3°C or higher or a leucocyte count higher than 10000 cells/mm3.

• Expected life expectancy ≥ 3 days

Exclusion Criteria:

• Patients have documented hypersensitivity to imipenem or other carbapenems.

• Patients have an estimated creatinine clearance < 60 ml/min

• Patients are in circulatory shock (defined as a systolic blood pressure of < 90 mmHg).

• Patients are pregnant.

• Pretient receive imipenem for 2 weeks before randomization.