PK/PD and Clinial Outcomes of Beta-lactams in ICU Patients
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|ClinicalTrials.gov Identifier: NCT03858387|
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : May 1, 2020
|Condition or disease||Intervention/treatment|
|Critical Illness Bacterial Infections||Drug: Meropenem Drug: Imipenem|
|Study Type :||Observational|
|Estimated Enrollment :||102 participants|
|Official Title:||Pharmacokinetics/Pharmacodynamics and Clinical Outcomes of β-lactams in Critically Ill Patients|
|Actual Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
Critically ill patients who require meropenem therapy
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.
Critically ill patients who require imipenem therapy
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.
Other Name: Imipenem/cilastatin
- 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)
- The relationship between %fT>MIC and clinical cure [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: during hospital stay and at day 28 ]All-cause mortality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858387
|Contact: Sutep o Jaruratanasirikul, M.D.||6674451485 ext firstname.lastname@example.org|
|Contact: Monchana o Nawakitrangsan, M.Pharm.||6674451485 ext email@example.com|
|Faculty of Medicine, Prince of Songkla University, Thailand||Recruiting|
|Hat Yai, Songkla, Thailand, 90110|
|Contact: Sutep Jaruratanasirikul, M.D. 6674-451485 firstname.lastname@example.org|
|Contact: Monchana Nawakitrangsan, M.Pharm 6674-451486 email@example.com|
|Principal Investigator: Sutep Jaruratanasirikul, M.D.|
|Principal Investigator:||Sutep Jaruratanasirikul, M.D.||Faculty of Medicine, Prince of Songkla University, Thailand|