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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-07

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Carbapenem Resistant Klebsiella Pneumoniae

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Prospective study compare historical controlled study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Dose antibiotics adjusted by pharmacokinetic and pharmacodynamic using Monte Carlo simulation

Group Type EXPERIMENTAL

Dose-adjustment by PKPD

Intervention Type DRUG

Dose-adjustment by pharmacokinetic and pharmacodynamic using Monte Carlo simulation

Control group

Dose antibiotics from standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dose-adjustment by PKPD

Dose-adjustment by pharmacokinetic and pharmacodynamic using Monte Carlo simulation

Intervention Type DRUG

Other Intervention Names

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Antibiotics: Ceftazidime-Avibactam or Combination antibiotics (eg. Meropenem-Colistin, Imipenem-Colistin, Tigecycline-Amikacin, Tigecycline-Gentamicin, Tigecycline-Meropenem or Tigecycline-Colistin)

Eligibility Criteria

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Inclusion Criteria

1. 20 years and older who admitted at Phramongkutklao Hospital
2. Patients who was diagnosed blood stream infection with CRKP between April 10th, 2023 to March 31st, 2024 (Prospective study) and January 1st, 2012 to March 31st, 2023 (Retrospective study); Historical group
3. Patients who had signs and symptoms at least 1 criteria following:

3.1. Patients who had signs and symptoms of Systemic Inflammatory Response Syndrome (SIRS) at least 2 criteria:
* Temperature above 38 oC or below 36 oC
* Heart rate more than 90 beats/min
* Respiratory rate more than 20 /min or PaCO2 less than 32 mmHg (4.3 kPa)
* White blood cell more than 12,000 cell/mm3 or less than 4,000 cell/mm3 3.2. Patients who was diagnosed sepsis or SOFA score or qSOFA score at least 2 score 3.3. Patients who was diagnosed septic shock or who had hypotension with adequate fluid and need for vasopressor to maintain mean arterial pressure over 65 mmHg and serum lactate above 2 mmol/L
4. Patients who received antibiotics at least 48 hours which are as follow:

* Ceftazidime-Avibactam or
* Combination antibiotics (eg. Meropenem-Colistin, Imipenem-Colistin, Tigecycline-Amikacin, Tigecycline- Gentamicin, Tigecycline-Meropenem or Tigecycline-Colistin)

Exclusion Criteria

1. Patients who were pregnancy or breastfeeding
2. Patients who had drug allergy (eg. Ceftazidime-Avibactam, Tigecycline, Amikacin, Gentamicin, Imipenem, Meropenem or Colistin)
3. Patients who not to received resuscitation.
4. Patients who were end stage cancer.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No