Community-Acquired InfectionsNCT03064464
CA-MRSA Infection in China: Epidemiology, Molecular Characteristics, Treatment, and Outcome
An observational study of Community-Acquired Infections and Methicillin-resistant Staphylococcus Aureus, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA), strains of MRSA that are able to infect otherwise healthy people outside of hospital settings, emerged in the late 1990s and have recently arisen in many countries around the globe. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Community-Acquired Infections, Methicillin-resistant Staphylococcus Aureus
- What is being tested?
- None Intervention
- How many people
- 5,400 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2016to 30 Jun 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All child and adult patients with Staphylococcus aureus visited any of the 60 particitant hospitals during the study period were included.
Who may be able to join
- Patients (Child, Adult) with infections caused by S. aureus from the sites as follows: blood stream, skin or soft tissue, cerebrospinal fluid, bone and joint, genitourinary tract, infection of indwelling intravascular device, surgical wound, respiratory tract (organism grown from sputum and infiltrate on chest X-ray), peritoneal fluid or other otherwise sterile body fluids.
Who cannot join
- Patients with S. aureus from anterior nares or throat swabs cultures for colonization screening purpose.
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, M.D.
About this study
Official title: Community-associated Staphylococcus Aureus Infections in China: Epidemiology, Molecular Characteristics, Treatment, and Outcome
Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA), strains of MRSA that are able to infect otherwise healthy people outside of hospital settings, emerged in the late 1990s and have recently arisen in many countries around the globe. CA-MRSA strains are usually distinguished from their HA-MRSA counterparts by the following characteristics: Firstly, CA-MRSA strains are usually susceptible to non-lactam antibiotics. Secondly, CA-MRSA harbors type IV and V SCCmec elements, which are shorter than the traditional type I, II, and III SCCmec elements found in HA-MRSA strains. Thirdly, certain successful clones are associated with outbreaks of CA-MRSA infections reported in specific geographical locations. For example, ST1 and ST8 isolates are mostly reported in the USA and Canada, ST80 isolates are commonly found in Europe, and ST59 isolates are encountered in the Asia-Pacific region. Notably, all these characteristics have substantial limitations for discriminating CA-MRSA isolates due to their complex backgrounds. Although there were more and more studies of CA-MRSA in European countries and the US, few national epidemiological data were available about China. In this study, we investigated the epidemiological, clinical and molecular characteristics of CA-MRSA isolates recovered in Chinese hospitals, in order to understand the changing epidemiology of MRSA in China.
Read the detailed description
Eligibility criteria:
- Inclusion criteria: Patients (Child, Adult) with infections caused by S. aureus from the sites as follows: blood stream, skin or soft tissue, cerebrospinal fluid, bone and joint, genitourinary tract, infection of indwelling intravascular device, surgical wound, respiratory tract (organism grown from sputum and infiltrate on chest X-ray), peritoneal fluid or other otherwise sterile body fluids.
- Exclusion criteria: Patients with S. aureus from anterior nares or throat swabs cultures (colonization).
Outcome measures:
- Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) infection rates in patients with S. aureus infections in Chinese hospitals.
- Risk factors and clinical outcomes of CA-MRSA infection
- Molecular characteristics of CA-MRSA isolates recovered in Chinese hospitals.
Definition:
A MRSA infection was considered to be HA-MRSA by the CDC epidemiologic definitions if, in the year prior to culture, the subject had surgery, hospitalization, hemodialysis or a stay in a long-term care facility, if an indwelling vascular catheter was in place at the time of culture, or if the subject was an inpatient hospitalized for 2 days at the time of culture. Otherwise, the subject was considered to have a CA-MRSA infection.
- Being tested
- None Intervention
- Keywords
- methicillin-resistant Staphylococcus aureus
- Medical subject headings
- Community-Acquired Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None InterventionOther
It is observational study, no interventios to any of the three study arms
| Study group | Role | What they receive |
|---|---|---|
| CA-MRSA infection | None intervention Receives: Other: None Intervention | |
| HA-MRSA infection | None intervention Receives: Other: None Intervention | |
| CA-MSSA infection | None intervention Receives: Other: None Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of CA-MRSA infections in China
Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) infection rates in patients with S. aureus infections in Chinese hospitals
Measured: During the study period (Two years)
Secondary outcomes (1)
Clonal Distribution of CA-MRSA in China
The distribution of sequence types in CA-MRSA isolates from China
Measured: During the study period (Two years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start15 Dec 2016
- Primary completion31 Dec 2017 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-Acquired InfectionsStudies 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
- 5,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-cang Zhou M.D., Sir Run Run Shaw Hospital
- Investigators
- Yun-song Yu, MD, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064464
- Sponsor's protocol ID
- SRRSH-MRSA01
- Status last verified
- Feb 2017
- First submitted
- 22 Feb 2017
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-associated Staphylococcus Aureus Infections in China: Epidemiology, Molecular Characteristics, Treatment, and Outcome
- ClinicalTrials.gov ID
- NCT03064464
- Acronym / sponsor ID
- SRRSH-MRSA01
- Keywords
- methicillin-resistant Staphylococcus aureus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,400 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 27 Feb 2017 (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.
Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA), strains of MRSA that are able to infect otherwise healthy people outside of hospital settings, emerged in the late 1990s and have recently arisen in many countries around the globe. CA-MRSA strains are usually distinguished from their HA-MRSA counterparts by the following characteristics: Firstly, CA-MRSA strains are usually susceptible to non-lactam antibiotics. Secondly, CA-MRSA harbors type IV and V SCCmec elements, which are shorter than the traditional type I, II, and III SCCmec elements found in HA-MRSA strains. Thirdly, certain successful clones are associated with outbreaks of CA-MRSA infections reported in specific geographical locations. For example, ST1 and ST8 isolates are mostly reported in the USA and Canada, ST80 isolates are commonly found in Europe, and ST59 isolates are encountered in the Asia-Pacific region. Notably, all these characteristics have substantial limitations for discriminating CA-MRSA isolates due to their complex backgrounds. Although there were more and more studies of CA-MRSA in European countries and the US, few national epidemiological data were available about China. In this study, we investigated the epidemiological, clinical and molecular characteristics of CA-MRSA isolates recovered in Chinese hospitals, in order to understand the changing epidemiology of MRSA in China.
Detailed description
Eligibility criteria:
- Inclusion criteria: Patients (Child, Adult) with infections caused by S. aureus from the sites as follows: blood stream, skin or soft tissue, cerebrospinal fluid, bone and joint, genitourinary tract, infection of indwelling intravascular device, surgical wound, respiratory tract (organism grown from sputum and infiltrate on chest X-ray), peritoneal fluid or other otherwise sterile body fluids.
- Exclusion criteria: Patients with S. aureus from anterior nares or throat swabs cultures (colonization).
Outcome measures:
- Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) infection rates in patients with S. aureus infections in Chinese hospitals.
- Risk factors and clinical outcomes of CA-MRSA infection
- Molecular characteristics of CA-MRSA isolates recovered in Chinese hospitals.
Definition:
A MRSA infection was considered to be HA-MRSA by the CDC epidemiologic definitions if, in the year prior to culture, the subject had surgery, hospitalization, hemodialysis or a stay in a long-term care facility, if an indwelling vascular catheter was in place at the time of culture, or if the subject was an inpatient hospitalized for 2 days at the time of culture. Otherwise, the subject was considered to have a CA-MRSA infection.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CA-MRSA infection | – | Other: None InterventionNone intervention |
| HA-MRSA infection | – | Other: None InterventionNone intervention |
| CA-MSSA infection | – | Other: None InterventionNone intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All child and adult patients with Staphylococcus aureus visited any of the 60 particitant hospitals during the study period were included.
Key inclusion criteria (1 listed)
- Patients (Child, Adult) with infections caused by S. aureus from the sites as follows: blood stream, skin or soft tissue, cerebrospinal fluid, bone and joint, genitourinary tract, infection of indwelling intravascular device, surgical wound, respiratory tract (organism grown from sputum and infiltrate on chest X-ray), peritoneal fluid or other otherwise sterile body fluids.
Key exclusion criteria (1 listed)
- Patients with S. aureus from anterior nares or throat swabs cultures for colonization screening purpose.
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 InterventionIt is observational study, no interventios to any of the three study arms | Other | CA-MRSA infection, CA-MSSA infection, HA-MRSA infection |
Primary outcome
The incidence of CA-MRSA infections in China
Time frame: During the study period (Two years)
Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) infection rates in patients with S. aureus infections in Chinese hospitals
1 secondary outcome
Clonal Distribution of CA-MRSA in China
Time frame: During the study period (Two years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- 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, MD principal investigator
Sir Run Run Shaw Hospital
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 Community-Acquired Infections and Methicillin-resistant Staphylococcus Aureus, 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 1 inclusion and 1 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 27 Feb 2017. 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 Jian-cang Zhou, MD (+86-571-8600-6142, jiancangzhou@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of CA-MRSA infections in China (time frame: During the study period (Two years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2017.