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Dose Optimization by Pharmacokinetic/Pharmacodynamic of Antibiotics to Improve Clinical Outcome of Carbapenem Resistant Klebsiella Pneumoniae Bloodstream Infections in Critically Ill Patients at Phramongkutklao Hospital

NCT05862402 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-05-17

No results posted yet for this study

Summary

The patients who infected with Carbapenem resistant Klebsiella pneumoniae were high mortality rate. Appropriate antibiotics therapy adjusted by Pharmacokinetic/Pharmacodynamic plays an important role in determining outcomes in Critically ill patients. Consequently, standard antibiotics dose may not be adequate to achieve pharmacokinetic/pharmacodynamic target in Critically ill patients. The purpose of this study is to compare the clinical outcomes between the critically ill patients who received antibiotics dose adjusted by pharmacokinetic/pharmacodynamic using Monte Carlo simulation and historical critically ill patients who received antibiotics from standard practice.

Conditions

  • Carbapenem Resistant Klebsiella Pneumoniae

Interventions

DRUG

Dose-adjustment by PKPD

Dose-adjustment by pharmacokinetic and pharmacodynamic using Monte Carlo simulation

Sponsors & Collaborators

  • Silpakorn University

    collaborator OTHER

  • Phramongkutklao College of Medicine and Hospital

    lead OTHER

Principal Investigators

  • Sujareenoot Suya, PharmD · Faculty of Pharmacy, Silpakorn University

  • Weerayuth Saelim, BCP · Faculty of Pharmacy, Silpakorn University

  • Wichai Santimaleeworagun, PhD · Faculty of Pharmacy, Silpakorn University

  • Worapong Nasomsong, MD · Phramongkutklao College of Medicine and Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-07
Primary Completion
2024-05-31
Completion
2024-06-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05862402 on ClinicalTrials.gov