Clinical trial NCT04310722: Gram-negative Bacilli and MRSA Screening in ICU in China
Official title: Dissemination and Resistance Mechanisms of Carbapenem-resistant Gram-negative Bacilli and Methicillin-resistant Staphylococcus Aureus in Intensive Care Units in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infections, Bacterial
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
Collaborators: name: University of Birmingham
First posted: 2020-03-17
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients whose primary diagnosis is infections caused by CRAB, CRKP, CRPsA, or MRSA

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Microbiological infection diagnosis
timeFrame: Through study completion, up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Yun-song Yu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: