Dose Optimization by Pharmacokinetic/Pharmacodynamic of A... | NCT05862402

Studies
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

NCT05862402

Sponsor

Phramongkutklao College of Medicine and Hospital

Status

Unknown status

Last Update Posted

May 17, 2023Actual

Enrollment

76Estimated

Phase

Phase 4

Conditions

Carbapenem Resistant Klebsiella Pneumoniae

Interventions

Dose-adjustment by PKPD

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 7, 2023Estimated

Primary Completion Date

May 31, 2024Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Apr 26, 2023

First Submission Date that Met QC Criteria

May 7, 2023

First Posted Date

May 17, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2023

Last Update Posted Date

May 17, 2023Actual

Name	Class
Silpakorn University	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	Dose antibiotics adjusted by pharmacokinetic and pharmacodynamic using Monte Carlo simulation	Drug: Dose-adjustment by PKPD
Control group	No Intervention	Dose antibiotics from standard care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dose-adjustment by PKPD	Drug	Dose-adjustment by pharmacokinetic and pharmacodynamic using Monte Carlo simulation	Intervention group

Measure	Description	Time Frame
Mortality	Alive or death	14 day

Measure	Description	Time Frame
Mortality	Alive or death	30 days
Microbiological cure rate	Evaluated culture of bloodstream	14 days

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sujareenoot Suya, PharmD	Contact	66814738170		Auensujareenoot@gmail.com
Weerayuth Saelim, BCP	Contact	66891705954		Saelim_w6@su.ac.th

Overall Officials

Name	Affiliation	Role
Sujareenoot Suya, PharmD	Faculty of Pharmacy, Silpakorn University	Study Chair
Weerayuth Saelim, BCP	Faculty of Pharmacy, Silpakorn University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Phramongkutklao Hospital	Recruiting	Ratchathewi	Bangkok	10400	Thailand

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms