Carbapenem Resistant Klebsiella Pneumoniae
Conditions
Keywords
Antibiotics, Dose optimization, Clinical outcome, CRKP, Critically ill
Brief 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.
Interventions
DRUGDose-adjustment by PKPD
Dose-adjustment by pharmacokinetic and pharmacodynamic using Monte Carlo simulation
Sponsors
Silpakorn University
Phramongkutklao College of Medicine and Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective study compare historical controlled study
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 14 day | Alive or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological cure rate | 14 days | Evaluated culture of bloodstream |
| Hospital length of stay | With in 30 days | Time interval (day) from hospital admission (after enrolled) to hospital discharge or death from any cause |
| ICU length of stay | With in 30 days | Time interval (day) from ICU admission (after enrolled) to ICU discharge or death from any cause |
| Clinical cure rate | Through treatment completion or with in 30 days | Evaluated sign and symptoms of infection or culture no growth |
| Duration of vasopressor or Inotropic agents | With in 30 days | Time interval (day) from time of vasopressor or Inotropic agents initiation to time to vasopressor or Inotropic agents discontinuation |
| Mortality | 30 days | Alive or death |
| Ventilator free day | 30 days | Day alive and free of ventilator |
| Vasopressor or Inotropic drug free day | 30 days | Day alive and free of vasopressor or inotropic drug |
| Procalcitonin | 14 days | Evaluated serum procalcitonin |
| Adverse event | Day 0, 5, 7 and finish course of Antibiotics or discharge | Evaluated side effect (eg. seizure, liver impairment, renal impairment) |
| Duration of ventilator | Assessed with in 30 days | Time interval (day) of ventilator |
Countries
Thailand
Contacts
Primary ContactSujareenoot Suya, PharmD
Backup ContactWeerayuth Saelim, BCP
Outcome results
None listed