Gram-negative Bacilli and MRSA Screening in ICU in China

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: Unknown
• Conditions: Infections, Bacterial
• Intervention / Treatment: Other: None intervention. This is an observational study.

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: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Microbiological infection diagnosis	Culture positive results confirmed the infection of CRAB, CRKP, CRPsA and MRSA; 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; 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

• Sponsor: Sir Run Run Shaw Hospital
• Collaborators: University of Birmingham
• Investigators: Principal Investigator: Yun-song Yu, Dr., Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2019
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID 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