Pharmacokinetics/Pharmacodynamics and Clinical Outcomes of β-lactams in Critically Ill Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Prince of Songkla University
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Population pharmacokinetic parameters of meropenem and imipenem
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Meropenem
Critically ill patients who require meropenem therapy
Intervention: Meropenem (Drug)
Imipenem
Critically ill patients who require imipenem therapy
Intervention: Imipenem (Drug)
Outcomes
Primary Outcomes
Population pharmacokinetic parameters of meropenem and imipenem
Time Frame: 24-48 hours after treatment
%fT>MIC of meropenem and imipenem
Time Frame: 24-48 hours after treatment
the percentage of time which the free drug concentration remains above the minimum inbibitory concentration (%fT\>MIC)
Secondary Outcomes
- The relationship between %fT>MIC and mortality(during hospital stay and at day 28)
- The relationship between %fT>MIC and clinical cure(Day 3-7 after treatment and end of therapy (7-14))
- The relationship between %fT>MIC and microbiological cure(Day 3-7 after treatment and end of therapy (7-14))
Investigators
Sutep Jaruratanasirikul
Department of Medicine, Faculty of Medicine, Prince of Songkla University
Prince of Songkla University