Bacterial Infections, Critical Illness
Conditions
Keywords
pharmacokinetics, pharmacodynamics, meropenem, imipenem
Brief summary
Meropenem and imipenem are broad-spectrum carbapenem antibiotic and are frequently prescribed in critically ill patients with severe infections. These patients show several pathophysiological changes that may alter the carbapenem pharmacokinetic (PK) normally found in other populations. Although the PK of carbapenems has been widely studied, most studies have been conducted on small populations, and clinical outcome data are sparse. Therefore, the aims of this study are (i) describe the population pharmacokinetic parameters of meropenem and imipenem in critically ill subject (ii) evaluate the pharmacodynamic of meropenem and imipenem as a predictor of clinical treatment outcome.
Interventions
DRUGMeropenem
This group is composed of 52 critically ill patients, meropenem dosage is chosen by the intensivist in charge of the case. Blood sampling: 5 blood samples (3 mL) were obtained from a heparinized intravascular catheter by direct venipuncture at the following time: before (time 0) and during 0-0.5 h, 0.5-2.5 h, 2.5-4 h, 4-8 h or 4-12 after meropenem administration.
DRUGImipenem
This group is composed of 50 critically ill patients, imipenem dosage is chosen by the intensivist in charge of the case. Blood sampling: 5 blood samples (3 mL) were obtained from a heparinized intravascular catheter by direct venipuncture at the following time: before (time 0) and during 0-0.5 h, 0.5-2 h, 2-4 h, 4-6 h or 4-12 after imipenem administration.
Sponsors
Prince of Songkla University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \>18 years * severely ill patient who admitted to medical or surgical intensive care unit who require a treatment with meropenem or imipenem antibiotic
Exclusion criteria
* severe renal impairment and require renal replacement therapy * APACHE II score \>30 * History of hypersensitivity to carbapenems * Pregnancy or breast-feeding female
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Population pharmacokinetic parameters of meropenem and imipenem | 24-48 hours after treatment | — |
| %fT>MIC of meropenem and imipenem | 24-48 hours after treatment | the percentage of time which the free drug concentration remains above the minimum inbibitory concentration (%fT\>MIC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The relationship between %fT>MIC and clinical cure | Day 3-7 after treatment and end of therapy (7-14) | Clinical cure: disappearance of all signs and symptoms related to the infection, such that no additional antibacterial therapy, drainage, or surgical procedure was required. |
| The relationship between %fT>MIC and microbiological cure | Day 3-7 after treatment and end of therapy (7-14) | Success is eradication (absence of the baseline pathogen in a specimen appropriately obtained from the original site of infection) or presumed eradication (absence of material to culture in a subject who was assessed as a clinical cure). |
| The relationship between %fT>MIC and mortality | during hospital stay and at day 28 | All-cause mortality |
Countries
Thailand
Contacts
Primary ContactSutep o Jaruratanasirikul, M.D.
Backup ContactMonchana o Nawakitrangsan, M.Pharm.
Outcome results
None listed