Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae

August 22, 2020 updated by: Phramongkutklao College of Medicine and Hospital

Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae: the Study of in Vitro Activity of Monotherapy and Combination Therapy, PK/PD Study and Treatment Outcomes

The purpose of this study is to evaluate the treatment outcomes in patients with CRE infections.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Antibiotic resistance is one of the major problems because of global burden. Resistant pathogens are non-susceptible to available antibiotics, causing of high clinical mortality (clinical impact) and high budget (economic impact), whereas new antibiotics in drug development are fewer. Carbapenem-Resistant Enterobacteriaceae (CRE) are categorized into one of the critical groups in World Health Organization's lists. In Thailand, the spread of CRE have been risen continuously since 2011.

Diverse actions are designed to address antibiotic resistance with limited resources, known as antimicrobial stewardship programs (ASPs). Dose-optimization by using PK/PD (Pharmacokinetics/Pharmacodynamics) application is recommendation of supplemental strategies in clinical routine practice. The benefit of the strategy is to reduce inappropriate antibiotic use and provide minimum resistance as well as maximum the success of clinical treatment.

Antibiotic combination regimens have a role for the CRE treatment. However, current evidence in clinical study is not concluded which the best or optimal combined antibiotics are. The reasons may be that combined antibiotics often vary among different sites of infection, causative pathogens, the patterns of local antimicrobial susceptibility and patient comorbidity. As the results, the antibiotic combination regimens for the treatment any infections caused by CRE is needed for further investigation. The anticipated result is to fill the limited data of the appropriate antibiotic regimens for individual Thai patients.

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Phramongkutklao Hospital

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Any patients are diagnosed any diseases caused by CRE infection by physicians at Phramongkutklao hospital during 1/4/2018 to 30/4/2021.
  2. Any patients are more than 18 years old.

  3. Any patients have at least 1 criterion as following 3.1 Any patients have at least 2 of the signs and symptoms of Systemic inflammatory response syndrome (SIRS), including

    • Fever (temperature > 38 °C) or hypothermia (temperature < 36°C)
    • Tachypnea (heart rate > 90 beats per minute)
    • Respiratory rate > 20 beats per minute or Paco2 < 32 mm Hg (4.3 kPa)
    • White blood cell count > 12,000 cells per millilitre (leukocytosis) or < 4,000 cells per milliliter (leukopenia) 3.2. Any patients are diagnosed with sepsis or have ≥ 2 points of Sequential Organ Failure Assessment (SOFA) Score or qSOFA (Quick SOFA) Score.

3.3. Any patients are diagnosed with septic shock or are received vasopressors (eg, dopamine, norepinephrine, epinephrine, vasopressin, phenylephrine), mean arterial pressure (MAP) < 65 mm Hg, and lactate > 2 mmol/L (18 mg/dL) 3.4 Any patients are received mechanical ventilation 3.5 Any patients are admitted at ICU ward.

Exclusion Criteria:

  1. Patients are breast-feeding or pregnancy.
  2. Patients are insufficient or incomplete information on the medical electronic record such as patients transferred.

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: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Optimal antibiotic combination regimens
The patients in the groups will be given the optimal antibiotic combination regimens.
Other: Combined antibiotic regimens
Combined antibiotic combinations defined as the optimal antibiotic combination regimens which are created from in vitro study and the application of PK/PD.
OTHER: Standard antibiotic regimens
The patients in the groups will be given the standard antibiotic regimens.
Other: Standard antibiotic regimens
Standard antibiotic regimens defined as the antibiotic regimens which are generally given to the patients following to the hospital protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical improvement or failure
Time Frame: up to 8 weeks
  • Clinical improvement was defined as resolution of the signs and symptoms of the infection with no change or addition antibiotic therapy at the end of treatment course, excepting de-escalation to a narrower spectrum antibiotic.
  • Clinical failure was defined as the signs and symptoms of the infection being more serious with change or addition antibiotic therapy against CRE.
up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Within 14 and 28/30 days after discharge
All cause mortality
Within 14 and 28/30 days after discharge
Length of stay
Time Frame: up to 12 weeks
The duration of a hospitalization
up to 12 weeks
Physician acceptance rates
Time Frame: up to 72 hours after reporting the bacterial culture results
The rates of physicians' acceptance of an recommended optimal regimen
up to 72 hours after reporting the bacterial culture results
Microbiological outcomes
Time Frame: Before discharge
Bacterial response in cultures after the treatment
Before discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phramongkutklao College of Medicine and Hospital

Investigators

  • Principal Investigator: Wichai Santimaleeworagun, Silpakorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

September 1, 2020

Primary Completion (ANTICIPATED)

March 1, 2021

Study Completion (ANTICIPATED)

April 1, 2021

Study Registration Dates

First Submitted

July 20, 2020

First Submitted That Met QC Criteria

August 14, 2020

First Posted (ACTUAL)

August 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 26, 2020

Last Update Submitted That Met QC Criteria

August 22, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Q011h/63

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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