- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05862402
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
May 7, 2023 updated by: Phramongkutklao College of Medicine and Hospital
Dose Optimization by PK/PD of Antibiotics to Improve Clinical Outcome of CRKP Bloodstream Infections in Critically Ill Patients and in Vitro Study of Monotherapy, Combination Therapy and Molecular Biology of Drug Resistance at Phramongkutklao Hospital: Prospective, Historical Controlled Study
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
76
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sujareenoot Suya, PharmD
- Phone Number: 66814738170
- Email: Auensujareenoot@gmail.com
Study Contact Backup
- Name: Weerayuth Saelim, BCP
- Phone Number: 66891705954
- Email: Saelim_w6@su.ac.th
Study Locations
-
-
Bangkok
-
Ratchathewi, Bangkok, Thailand, 10400
- Recruiting
- Phramongkutklao Hospital
-
Contact:
- Sujareenoot Suya, PharmD
- Phone Number: 66814738170
- Email: Auensujareenoot@gmail.com
-
Contact:
- Weerayuth Saelim, BCP
- Phone Number: 66891705954
- Email: Saelim_w6@su.ac.th
-
Principal Investigator:
- Sujareenoot Suya, PharmD
-
Principal Investigator:
- Weerayuth Saelim, BCP
-
Sub-Investigator:
- Wichai Santimaleeworagun, PhD
-
Sub-Investigator:
- Worapong Nasomsong, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 20 years and older who admitted at Phramongkutklao Hospital
- 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
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
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:
- Patients who were pregnancy or breastfeeding
- Patients who had drug allergy (eg. Ceftazidime-Avibactam, Tigecycline, Amikacin, Gentamicin, Imipenem, Meropenem or Colistin)
- Patients who not to received resuscitation.
- Patients who were end stage cancer.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Dose antibiotics adjusted by pharmacokinetic and pharmacodynamic using Monte Carlo simulation
|
Dose-adjustment by pharmacokinetic and pharmacodynamic using Monte Carlo simulation
Other Names:
|
No Intervention: Control group
Dose antibiotics from standard care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 14 day
|
Alive or death
|
14 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 30 days
|
Alive or death
|
30 days
|
Microbiological cure rate
Time Frame: 14 days
|
Evaluated culture of bloodstream
|
14 days
|
Hospital length of stay
Time Frame: With in 30 days
|
Time interval (day) from hospital admission (after enrolled) to hospital discharge or death from any cause
|
With in 30 days
|
ICU length of stay
Time Frame: With in 30 days
|
Time interval (day) from ICU admission (after enrolled) to ICU discharge or death from any cause
|
With in 30 days
|
Clinical cure rate
Time Frame: Through treatment completion or with in 30 days
|
Evaluated sign and symptoms of infection or culture no growth
|
Through treatment completion or with in 30 days
|
Duration of vasopressor or Inotropic agents
Time Frame: With in 30 days
|
Time interval (day) from time of vasopressor or Inotropic agents initiation to time to vasopressor or Inotropic agents discontinuation
|
With in 30 days
|
Duration of ventilator
Time Frame: Assessed with in 30 days
|
Time interval (day) of ventilator
|
Assessed with in 30 days
|
Ventilator free day
Time Frame: 30 days
|
Day alive and free of ventilator
|
30 days
|
Vasopressor or Inotropic drug free day
Time Frame: 30 days
|
Day alive and free of vasopressor or inotropic drug
|
30 days
|
Procalcitonin
Time Frame: 14 days
|
Evaluated serum procalcitonin
|
14 days
|
Adverse event
Time Frame: Day 0, 5, 7 and finish course of Antibiotics or discharge
|
Evaluated side effect (eg. seizure, liver impairment, renal impairment)
|
Day 0, 5, 7 and finish course of Antibiotics or discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Sujareenoot Suya, PharmD, Faculty of Pharmacy, Silpakorn University
- Study Director: Weerayuth Saelim, BCP, Faculty of Pharmacy, Silpakorn University
- Study Director: Wichai Santimaleeworagun, PhD, Faculty of Pharmacy, Silpakorn University
- Study Director: Worapong Nasomsong, MD, Phramongkutklao College of Medicine and Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 7, 2023
Primary Completion (Anticipated)
May 31, 2024
Study Completion (Anticipated)
June 30, 2024
Study Registration Dates
First Submitted
April 26, 2023
First Submitted That Met QC Criteria
May 7, 2023
First Posted (Actual)
May 17, 2023
Study Record Updates
Last Update Posted (Actual)
May 17, 2023
Last Update Submitted That Met QC Criteria
May 7, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Systemic Inflammatory Response Syndrome
- Inflammation
- Disease Attributes
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Enterobacteriaceae Infections
- Sepsis
- Pneumonia
- Critical Illness
- Klebsiella Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Antitubercular Agents
- beta-Lactamase Inhibitors
- Anti-Bacterial Agents
- Antibiotics, Antitubercular
- Gentamicins
- Imipenem
- Tigecycline
- Meropenem
- Colistin
- Avibactam
- Amikacin
- Ceftazidime
Other Study ID Numbers
- PMK-0008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carbapenem Resistant Klebsiella Pneumoniae
-
Soroka University Medical CenterUnknown
-
Sir Run Run Shaw HospitalRecruitingHematological Diseases | Carbapenem-resistant Enterobacteriaceae | Carbapenem-resistant Pseudomonas Aeruginosa | Carbapenem-resistant Acinetobacter BaumanniiChina
-
Virginia Commonwealth UniversityCompletedRelationship of Carbapenem Use to Carbapenem Resistant Gram-negative BacteriaUnited States
-
Chuncheon Sacred Heart HospitalSeverance Hospital; National Institute of Health, KoreaRecruitingCarbapenem-Resistant Enterobacteriaceae | Vancomycin (Glycopeptide) Resistant Enterococcus (VRE)Korea, Republic of
-
Rambam Health Care CampusCompletedKlebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or PneumoniaIsrael
-
Al-Azhar UniversityUnknownTreatment of Blood Stream Infections Due to Multidrug-Resistant Klebsiella PneumoniaeEgypt
-
University of BolognaHospital General Universitario Gregorio Marañon; IRCCS ISMETT Palermo; ASST-Sette... and other collaboratorsNot yet recruitingLiver Transplantation | Carbapenem-Resistant Enterobacteriaceae ColonizationSpain, Brazil, Italy
-
Fondazione Policlinico Universitario Agostino Gemelli...CompletedCarbapenem | Klebsiella Pneumonia
-
Universidad del NorteUnknownUrinary Tract Infections | Enterobacteriaceae Infections | Clinical Trial | Carbapenem | Klebsiella Pneumoniae Infection | Infection Due to ESBL Bacteria | Escherichia Coli Infection | Drug Resistance, BacterialColombia
-
LimmaTech Biologics AGGlaxoSmithKlineCompletedKlebsiella Pneumoniae InfectionGermany
Clinical Trials on Dose-adjustment by PKPD
-
Hospital de Clinicas de Porto AlegreUnknownStress Urinary Incontinence | Urinary Retention Postoperative | Urinary Retention After ProcedureBrazil
-
Hadassah Medical OrganizationRecruitingAminoglycoside Dosing Based on PK/PD CharacteristicsIsrael
-
University Hospital Schleswig-HolsteinCompleted
-
University of LouisvilleNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Beijing Tongren HospitalCompletedAllergic Rhinitis | ImmunotherapyChina
-
Belfast Health and Social Care TrustHoffmann-La Roche; Medical Research Council; Aerocrine ABCompletedSevere Persistent AsthmaUnited Kingdom
-
Shanghai Zhongshan HospitalShanghai Fifth People's Hospital,Fudan UniversityNot yet recruiting
-
CR-CSSS Champlain-Charles-Le MoyneCompletedAdult | Vancomycin | Area Under CurveCanada
-
Murdoch Childrens Research InstituteSydney Children's Hospitals Network; Royal Children's Hospital; Monash Health; Royal...Not yet recruitingInfections | Sepsis | BacteremiaAustralia
-
University of Texas Southwestern Medical CenterCompletedAnesthesia, LocalUnited States