Carbapenem Resistant Klebsiella PneumoniaePhase 4NCT05862402
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
A Phase 4 study testing Dose-adjustment by PKPD in people with Carbapenem Resistant Klebsiella Pneumoniae, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carbapenem Resistant Klebsiella Pneumoniae
- What is being tested?
- Dose-adjustment by PKPD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteThailand
- Study dates
- 7 May 2023to 30 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Phramongkutklao Hospital
Ratchathewi, Bangkok, 10400
Sujareenoot Suya, PharmD, 66814738170, Auensujareenoot@gmail.com
Weerayuth Saelim, BCP, 66891705954, Saelim_w6@su.ac.th
About this study
Official title: 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.
- Being tested
- Dose-adjustment by PKPD
- Keywords
- Antibiotics, Dose optimization, Clinical outcome, CRKP, Critically ill
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose-adjustment by PKPDDrug
Also called Antibiotics: Ceftazidime-Avibactam or Combination antibiotics (eg. Meropenem-Colistin, Imipenem-Colistin, Tigecycline-Amikacin, Tigecycline-Gentamicin, Tigecycline-Meropenem or Tigecycline-Colistin)
Dose-adjustment by pharmacokinetic and pharmacodynamic using Monte Carlo simulation
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Dose antibiotics adjusted by pharmacokinetic and pharmacodynamic using Monte Carlo simulation Receives: Drug: Dose-adjustment by PKPD |
| Control group | No intervention | Dose antibiotics from standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Alive or death
Measured: 14 day
Secondary outcomes (11)
Mortality
Alive or death
Measured: 30 days
Microbiological cure rate
Evaluated culture of bloodstream
Measured: 14 days
Hospital length of stay
Time interval (day) from hospital admission (after enrolled) to hospital discharge or death from any cause
Measured: With in 30 days
ICU length of stay
Time interval (day) from ICU admission (after enrolled) to ICU discharge or death from any cause
Measured: With in 30 days
Clinical cure rate
Evaluated sign and symptoms of infection or culture no growth
Measured: Through treatment completion or with in 30 days
Duration of vasopressor or Inotropic agents
Time interval (day) from time of vasopressor or Inotropic agents initiation to time to vasopressor or Inotropic agents discontinuation
Measured: With in 30 days
Duration of ventilator
Time interval (day) of ventilator
Measured: Assessed with in 30 days
Ventilator free day
Day alive and free of ventilator
Measured: 30 days
Vasopressor or Inotropic drug free day
Day alive and free of vasopressor or inotropic drug
Measured: 30 days
Procalcitonin
Evaluated serum procalcitonin
Measured: 14 days
Adverse event
Evaluated side effect (eg. seizure, liver impairment, renal impairment)
Measured: Day 0, 5, 7 and finish course of Antibiotics or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start7 May 2023 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbapenem Resistant Klebsiella PneumoniaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective study compare historical controlled study
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Silpakorn University
- Responsible party
- Sponsor
- Investigators
- Sujareenoot Suya, PharmD, Study chair, Faculty of Pharmacy, Silpakorn UniversityWeerayuth Saelim, BCP, Study director, Faculty of Pharmacy, Silpakorn UniversityWichai Santimaleeworagun, PhD, Study director, Faculty of Pharmacy, Silpakorn UniversityWorapong Nasomsong, MD, Study director, Phramongkutklao College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862402
- Sponsor's protocol ID
- PMK-0008
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05862402
- Acronym / sponsor ID
- PMK-0008
- Keywords
- Antibiotics, Dose optimization, Clinical outcome, CRKP, Critically ill
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Collaborators
- Silpakorn University
- Study start
- 7 May 2023 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective study compare historical controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Dose-adjustment by PKPDDose antibiotics adjusted by pharmacokinetic and pharmacodynamic using Monte Carlo simulation |
| Control group | No intervention | –Dose antibiotics from standard care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Patients who received antibiotics at least 48 hours which are as follow:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose-adjustment by PKPDAlso: Antibiotics: Ceftazidime-Avibactam or Combination antibiotics (eg. Meropenem-Colistin, Imipenem-Colistin, Tigecycline-Amikacin, Tigecycline-Gentamicin, Tigecycline-Meropenem or Tigecycline-Colistin)Dose-adjustment by pharmacokinetic and pharmacodynamic using Monte Carlo simulation | Drug | Intervention group |
Primary outcome
Mortality
Time frame: 14 day
Alive or death
11 secondary outcomes
Mortality
Time frame: 30 days
Microbiological cure rate
Time frame: 14 days
Hospital length of stay
Time frame: With in 30 days
ICU length of stay
Time frame: With in 30 days
Clinical cure rate
Time frame: Through treatment completion or with in 30 days
Duration of vasopressor or Inotropic agents
Time frame: With in 30 days
Duration of ventilator
Time frame: Assessed with in 30 days
Ventilator free day
Time frame: 30 days
Vasopressor or Inotropic drug free day
Time frame: 30 days
Procalcitonin
Time frame: 14 days
Adverse event
Time frame: Day 0, 5, 7 and finish course of Antibiotics or discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
Related trials for Carbapenem Resistant Klebsiella Pneumoniae
Not yet recruitingObservational study
Impact of Siderophore Genes on Cefiderocol Susceptibility in Carbapenem Resistant Hypervirulent Klebsiella Pneumoniae
Carbapenem-resistant Hypervirulent Klebsiella Pneumoniae Infection
Active, not recruitingPhase 2
Pentaglobin in CRE and PA Neutropenic Infections
Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sujareenoot Suya, PharmD study chair
Faculty of Pharmacy, Silpakorn University
Weerayuth Saelim, BCP study director
Faculty of Pharmacy, Silpakorn University
Wichai Santimaleeworagun, PhD study director
Faculty of Pharmacy, Silpakorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dose-adjustment by PKPD in people with Carbapenem Resistant Klebsiella Pneumoniae, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sujareenoot Suya, PharmD (66814738170, Auensujareenoot@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 14 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.