Patients With Febrile Neutropenia
Conditions
Keywords
Imipenem, Febrile neutropenia, Gram-negative infection, Pharmacodynamic, Monte Carlo Simulation
Brief summary
This is prospective and randomized study to compare the pharmacodynamics (t\>MIC) of 0.5 g every 6 h of imipenem in twelve patients with febrile neutropenia following administration by a 4 h infusion or bolus injection. Concentration of imipenem in plasma will be measured by HPLC method and 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.
Interventions
DRUGImipenem
Each patient will receive 0.5 g of imipenem, 0.5 hr infusion every 6 hr at room temperature
Sponsors
Merck Sharp & Dohme LLC
Prince of Songkla University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged \> or = 20 years * Patients who have febrile neutropenia with Gram negative bacilli infections which are sensitive to imipenem by the disk diffusion * Patients who are likely to survive 3 days
Exclusion criteria
* Patients who have documented hypersensitivity to imipenem or other carbapenems * Patients who have an estimated creatinine clearance of \< 50 ml/min * Patients who are in circulatory shock or hypotension (systolic \< 90 mmHg) * Patients who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of imipenem in plasma | 6 hours profile after 8th dose of imipenem | Concentration of imipenem in plasma will be determined by HPLC method and 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). |
Countries
Thailand
Outcome results
None listed