Gram-negative Bacilli and MRSA Screening in ICU in China

Infections, Bacterial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04310722
• Other study ID #: SRRSH-DETECTIVE-CHINA
• Status: Recruiting
• Start date: August 6, 2019
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: Sir Run Run Shaw Hospital
• Contact: Ying-zhi Fang, Master
• Phone: +86 57186006811
• Email: fyz4817[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Infections, Bacterial

Intervention

Other:
• None intervention. This is an observational study.
None intervention. This is an observational study.

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital	University of Birmingham

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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