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
- Conditions
- The clinical outcomes in CRKP infected patients who received antibiotics dose adjusted by pharmacokinetic/pharmacodynamic were not study.Antibiotics, Dose optimization, Clinical outcome, CRKP, Critically ill
- Registration Number
- TCTR20230411001
- Lead Sponsor
- Faculty of Pharmacy, Silpakorn University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 76
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)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality 14 day Alive or death
- Secondary Outcome Measures
Name Time Method Mortality 30 days Alive or death,Microbiological cure rate 14 days evaluated culture of bloodstream,Hospital length of stay During Hospital stay or death or Discharge Duration of hospital stay,ICU length of stay During ICU stay or death or Discharge Duration of ICU stay,Clinical cure rate Course of antibiotics Evaluated sign and symptoms of infection or culture no growth,Duration of vasopressor or Inotropic agents follow up thrice until discharge Time interval (day) from time of vasopressor agents initiation to time to vasopressor agents discontinuation,Duration of ventilator follow up thrice until discharge Time interval (day) of ventilator,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)