NCT05862402

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

May 7, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

May 17, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

April 26, 2023

Last Update Submit

May 7, 2023

Conditions

Carbapenem Resistant Klebsiella Pneumoniae

Keywords

AntibioticsDose optimizationClinical outcomeCRKPCritically ill

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Alive or death

    14 day

Secondary Outcomes (11)

  • Mortality

    30 days

  • Microbiological cure rate

    14 days

  • Hospital length of stay

    With in 30 days

  • ICU length of stay

    With in 30 days

  • Clinical cure rate

    Through treatment completion or with in 30 days

  • +6 more secondary outcomes

Study Arms (2)

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

Dose-adjustment by PKPDDRUG

Dose-adjustment by pharmacokinetic and pharmacodynamic using Monte Carlo simulation

Also known as: Antibiotics: Ceftazidime-Avibactam or Combination antibiotics (eg. Meropenem-Colistin, Imipenem-Colistin, Tigecycline-Amikacin, Tigecycline-Gentamicin, Tigecycline-Meropenem or Tigecycline-Colistin)
Intervention group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phramongkutklao Hospital

Ratchathewi, Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sujareenoot Suya, PharmD

    Faculty of Pharmacy, Silpakorn University

    STUDY CHAIR

  • 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 DIRECTOR

Central Study Contacts

Sujareenoot Suya, PharmD

CONTACT

66814738170Auensujareenoot@gmail.com

Weerayuth Saelim, BCP

CONTACT

66891705954Saelim_w6@su.ac.th

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective study compare historical controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2023

First Posted

May 17, 2023

Study Start

May 7, 2023

Primary Completion

May 31, 2024

Study Completion

June 30, 2024

Last Updated

May 17, 2023

Record last verified: 2023-04

Locations

TH(1)