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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
Sponsor:
Information provided by (Responsible Party):
Sutep Jaruratanasirikul, Prince of Songkla University

Study Description
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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.

Condition or disease Intervention/treatment
Critical Illness Bacterial Infections Drug: Meropenem Drug: Imipenem

Study Design
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Study Type : Observational
Estimated Enrollment : 102 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Meropenem
Critically ill patients who require meropenem therapy
 Drug: Meropenem

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.
Imipenem
Critically ill patients who require imipenem therapy
 Drug: Imipenem

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


Outcome Measures
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Primary Outcome Measures :
  1. Population pharmacokinetic parameters of meropenem and imipenem [ Time Frame: 24-48 hours after treatment ]
  2. %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 Outcome Measures :
  1. 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.

  2. 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).

  3. The relationship between %fT>MIC and mortality [ Time Frame: during hospital stay and at day 28 ]
    All-cause mortality


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Sutep o Jaruratanasirikul, M.D. 6674451485 ext 6674451485 jasutep@medicine.psu.ac.th
Contact: Monchana o Nawakitrangsan, M.Pharm. 6674451485 ext 6674451485 nana_jittung@hotmail.com

Locations
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Thailand
Faculty of Medicine, Prince of Songkla University, Thailand Recruiting
Hat Yai, Songkla, Thailand, 90110
Contact: Sutep Jaruratanasirikul, M.D.    6674-451485    jasutep@medicine.psu.ac.th   
Contact: Monchana Nawakitrangsan, M.Pharm    6674-451486    nana_jittung@hotmail.com   
Principal Investigator: Sutep Jaruratanasirikul, M.D.         
Sponsors and Collaborators
Prince of Songkla University
Investigators
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Principal Investigator: Sutep Jaruratanasirikul, M.D. Faculty of Medicine, Prince of Songkla University, Thailand
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sutep Jaruratanasirikul, Department of Medicine, Faculty of Medicine, Prince of Songkla University, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT03858387    
Other Study ID Numbers: B-lactams-ICU-61061141
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sutep Jaruratanasirikul, Prince of Songkla University:
pharmacokinetics
pharmacodynamics
meropenem
imipenem
Additional relevant MeSH terms:
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Bacterial Infections
Critical Illness
Disease Attributes
Pathologic Processes
Bacterial Infections and Mycoses
Infections
Meropenem
 Imipenem
Cilastatin
Anti-Bacterial Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action