Infections, BacterialNCT04310722
Gram-negative Bacilli and MRSA Screening in ICU in China
An observational study of Infections, Bacterial, run by Sir Run Run Shaw Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Infections, Bacterial
- What is being tested?
- None intervention. This is an observational study.
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2019to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients whose primary diagnosis is infections caused by CRAB, CRKP, CRPsA, or MRSA
Who may be able to join
- 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
Who cannot join
- Mixed infections of other pathogens
- Virus infections
- Other infections caused by other pathogens, such as fungus
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
Ying-zhi Fang, +86 571 86006987
Yun-song Yu, Dr.
About this study
Official title: 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.
Read the 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.
- Conditions
- Infections, Bacterial
- Being tested
- None intervention. This is an observational study.
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None intervention. This is an observational study.Other
None intervention. This is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: None intervention. This is an observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Through study completion, up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start6 Aug 2019
- Primary completionOct 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infections, BacterialStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham
- Responsible party
- Principal investigator, Jian-cang Zhou M.D., Sir Run Run Shaw Hospital
- Investigators
- Yun-song Yu, Dr., Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310722
- Sponsor's protocol ID
- SRRSH-DETECTIVE-CHINA
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 20 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Min P, Xu H, Pan H, Chen S, Yao J, Li S, Ding X, Hua X, Li X, Yu Y, Zhou H, Liu H. Genomic and phenotypic characterization of carbapenem-resistant Acinetobacter baumannii isolates from patients and trolleys and their potential connections in an intensive care unit. BMC Microbiol. 2026 May 25;26(1):651. doi: 10.1186/s12866-026-05217-y.
PubMed 42185782
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination and Resistance Mechanisms of Carbapenem-resistant Gram-negative Bacilli and Methicillin-resistant Staphylococcus Aureus in Intensive Care Units in China
- ClinicalTrials.gov ID
- NCT04310722
- Acronym / sponsor ID
- SRRSH-DETECTIVE-CHINA
- Conditions
- Infections, Bacterial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Collaborators
- University of Birmingham
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gram-negative bacilli and MRSA infections in ICU | – | Other: None intervention. This is an observational study.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. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients whose primary diagnosis is infections caused by CRAB, CRKP, CRPsA, or MRSA
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Mixed infections of other pathogens
- Virus infections
- Other infections caused by other pathogens, such as fungus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None intervention. This is an observational study.None intervention. This is an observational study. | Other | Gram-negative bacilli and MRSA infections in ICU |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Derived from this study: PubMed 42185782Min P, Xu H, Pan H, Chen S, Yao J, Li S, Ding X, Hua X, Li X, Yu Y, Zhou H, Liu H. Genomic and phenotypic characterization of carbapenem-resistant Acinetobacter baumannii isolates from patients and trolleys and their potential connections in an intensive care unit. BMC Microbiol. 2026 May 25;26(1):651. doi: 10.1186/s12866-026-05217-y.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun-song Yu, Dr. principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Bacterial, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying-zhi Fang, Master (+86 57186006811, fyz4817@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological infection diagnosis (time frame: Through study completion, up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04310722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.