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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meropenem | Critically ill patients who require meropenem therapy |
| |
| Imipenem | Critically ill patients who require imipenem therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meropenem | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Population pharmacokinetic parameters of meropenem and imipenem | 24-48 hours after treatment | |
| %fT>MIC of meropenem and imipenem | the percentage of time which the free drug concentration remains above the minimum inbibitory concentration (%fT>MIC) | 24-48 hours after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The relationship between %fT>MIC and clinical cure | Clinical cure: disappearance of all signs and symptoms related to the infection, such that no additional antibacterial therapy, drainage, or surgical procedure was required. | Day 3-7 after treatment and end of therapy (7-14) |
| The relationship between %fT>MIC and microbiological cure |
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Inclusion Criteria:
Exclusion Criteria:
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Critically ill patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sutep o Jaruratanasirikul, M.D. | Contact | 6674451485 | 6674451485 | jasutep@medicine.psu.ac.th |
| Monchana o Nawakitrangsan, M.Pharm. | Contact | 6674451485 | 6674451485 | nana_jittung@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sutep Jaruratanasirikul, M.D. | Faculty of Medicine, Prince of Songkla University, Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Prince of Songkla University, Thailand | Recruiting | Hat Yai | Changwat Songkhla | 90110 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34080708 | Derived | Jaruratanasirikul S, Boonpeng A, Nawakitrangsan M, Samaeng M. NONMEM population pharmacokinetics and Monte Carlo dosing simulations of imipenem in critically ill patients with life-threatening severe infections during support with or without extracorporeal membrane oxygenation in an intensive care unit. Pharmacotherapy. 2021 Jul;41(7):572-597. doi: 10.1002/phar.2597. Epub 2021 Jun 18. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D000077731 | Meropenem |
| D015378 | Imipenem |
| D000077728 | Cilastatin, Imipenem Drug Combination |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
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|
| Imipenem | Drug | 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. |
|
|
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). |
| Day 3-7 after treatment and end of therapy (7-14) |
| The relationship between %fT>MIC and mortality | All-cause mortality | during hospital stay and at day 28 |
| D007239 | Infections |
| Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D015377 | Cilastatin |
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |