Gram-negative Bacilli and MRSA Screening in ICU in China

March 18, 2020 updated by: Jian-cang Zhou M.D., Sir Run Run Shaw Hospital

Dissemination and Resistance Mechanisms of Carbapenem-resistant Gram-negative Bacilli and Methicillin-resistant Staphylococcus Aureus in Intensive Care Units in China

Carbapenem-resistant Gram-negative bacilli [Carbapenem-resistant Acinetobacter baumannii (CRAB), Carbapenem-resistant Klebsiella pneumoniae (CRKP), and Carbapenem-resistant Pseudomonas aeruginosa (CRPsA) ] and methicillin-resistant Staphylococcus aureus (MRSA) is prevalent around the world, and the isolation rate and resistance rate has increasing in China. The limited treatment and high mortality rate of these pathogens infections has resulted in difficulty in clinical anti-infection treatment, so it is urgent to illustrate the transmission mechanism, resistance mechanism and horizontal transfer mechanism of resistance genes in intensive care unit (ICU). Furthermore, this study was aimed to investigate the epidemiology and risk factors, outcomes and the rationality of the current therapy for these pathogens infections in China.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Based on the previous study, investigators plan to screen for CRKP, CRAB, CRPsA and MRSA isolates from ICU settings, medical workers and patients, and establish the CRKP, CRAB, CRPsA and MRSA genome and transcriptome database through next-generation sequencing. Under the guide of British bioinformatics and hospital-acquired infection control experts, investigators will build the transmission mechanism model of CRKP, CRAB, CRPsA and MRSA combined with the clinical data to reveal the route and rule of transmission. And the study will also demonstrate that the resistance mechanism and horizontal transfer mechanism of resistance genes of carbapenems and other main antimicrobial agents. Investigators will also set up alerting platform and new antibiotic susceptible system based on the genome and transcriptome. These results will provide scientific evidence to rational application of antimicrobial agents, reduction the prevalence of CRKP, CRAB, CRPsA and MRSA, improvement the prognosis of infections and development of new antimicrobial agents. Finally, to find the prevalence, risk factors, outcome and the rationality of the current therapy for these pathogens infections in China.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital
        • Contact:
          • Ying-zhi Fang
          • Phone Number: +86 571 86006987
        • Principal Investigator:
          • Yun-song Yu, Dr.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients whose primary diagnosis is infections caused by CRAB, CRKP, CRPsA, or MRSA

Description

Inclusion Criteria:

  • Patients infected by CRAB isolated from throat swabs, rectal swabs, gastric tubes, tracheal intubations, tracheostomy tubes, and nasointestinal tubes
  • Patients infected by CRKP isolated from throat swabs, rectal swabs, gastric tubes, tracheal intubations, tracheostomy tubes, and nasointestinal tubes
  • Patients infected by CRPsA isolated from throat swabs, rectal swabs, gastric tubes, tracheal intubations, tracheostomy tubes, and nasointestinal tubes
  • Patients infected by MRSA collected from throat swabs, rectal swabs, gastric tubes, tracheal intubations, tracheostomy tubes, and nasointestinal tubes

Exclusion Criteria:

  • Mixed infections of other pathogens
  • Virus infections
  • Other infections caused by other pathogens, such as fungus

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Gram-negative bacilli and MRSA infections in ICU
Carbapenem-resistant Gram-negative bacilli [Carbapenem-resistant Acinetobacter baumannii (CRAB), Carbapenem-resistant Klebsiella pneumoniae (CRKP), and Carbapenem-resistant Pseudomonas aeruginosa (CRPsA) ] and methicillin-resistant Staphylococcus aureus (MRSA) is prevalent around the world, and the isolation rate and resistance rate has increasing in China, especially in ICU. So, investigators aim to study transmission mechanism, resistance mechanism and horizontal transfer mechanism of these pathogens.
Other: None intervention. This is an observational study.
None intervention. This is an observational study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Microbiological infection diagnosis
Time Frame: Through study completion, up to one year
  1. Culture positive results confirmed the infection of CRAB, CRKP, CRPsA and MRSA
  2. 8 participants will collect the samples from the patients and environment in one ICU and isolation rate of CRAB, CRKP, CRPsA and MRSA will be obtained
  3. Molecular characteristics of CRAB, CRKP, CRPsA and MRSA using multilocus sequence type (MLST), pulsed field gel electrophoresis (PFGE) and whole-genome sequencing (WGS)
Through study completion, up to one year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sir Run Run Shaw Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yun-song Yu, Dr., Zhejiang University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 6, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SRRSH-DETECTIVE-CHINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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