MRSANCT04312776
Tracing MRSA in Households With Patients Infected With CA-MRSA by WGS
An observational study of MRSA, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
From the 1980s to the late 1990s, highly toxic methicillin-resistant Staphylococcus aureus (MRSA) strains (called community-associated [CA] MRSA) appeared in the community. Although the prevalence of HA-MRSA (health-related MRSA) infection remained stable between 1998 and 2008, the CA-MRSA (community-related MRSA)… Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- MRSA
- What is being tested?
- none intervention
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2019to 17 Mar 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: No special requirements
Who may be able to join
- Patients (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 risk factors for nosocomial or medically related infections, and patients who have been decolonized (using mupirocin, chlorhexidine or bleach) in the past month.
Trial locations and contacts
1 site in 1 country.
About this study
From the 1980s to the late 1990s, highly toxic methicillin-resistant Staphylococcus aureus (MRSA) strains (called community-associated [CA] MRSA) appeared in the community. Although the prevalence of HA-MRSA (health-related MRSA) infection remained stable between 1998 and 2008, the CA-MRSA (community-related MRSA) infection rate increased. By far, the most common manifestations of CA-MRSA related diseases are skin and soft tissue infections. Skin and soft tissue infections (SSTIs) account for at least 90% of CA-MRSA infections. CA-MRSA strains also cause bone and joint infections, such as osteomyelitis and respiratory infections, such as pneumonia, sepsis, and urinary tract infections. Given that Staphylococcus aureus can live in the home as a settler or environmental pollutant, the environment can be used as a medium for obtaining and transmitting MRSA. In addition, transmission of MRSA between pets and humans has been proposed, but the directionality is unclear. In this study, we report an in-depth epidemiological and genomics study of a community-associated methicillin-resistant Staphylococcus aureus infection in SSRSH, Zhejiang Province, 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 risk factors for nosocomial or medically related infections, and patients who have been decolonized (using mupirocin, chlorhexidine or bleach) in the past month.
Outcome measures:
- Isolation rate of staphylococcus aureus and methicillin-resistant staphylococcus aureus on domestic environment, contact and pets and livestock.
- Molecular characteristics of CA-MRSA isolates recovered in Chinese hospitals, home environments, contacts, and pets and livestock.
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.
- Conditions
- MRSA
- Being tested
- none intervention
- Keywords
- MRSA, Whole-genome sequencing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Patients infected with CA-MRSA | It is an observational study, no interventions to any of the two study arms. Receives: Other: none intervention | |
| Healthy people without any infection | It is an observational study, no interventions to any of the two study arms. Receives: Other: none intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clonal Distribution of CA-MRSA in China The distribution of sequence types in CA-MRSA isolates from China
Measured: During the study period (One years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start15 Nov 2019
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRSAStudies 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
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
- NCT04312776
- Sponsor's protocol ID
- SRRSH-Household01
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2020
- Last updated
- 18 Mar 2020
- 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 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracing MRSA in Households With Patients Infected With CA-MRSA by WGS
- ClinicalTrials.gov ID
- NCT04312776
- Acronym / sponsor ID
- SRRSH-Household01
- Conditions
- MRSA
- Keywords
- MRSA, Whole-genome sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 18 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.
From the 1980s to the late 1990s, highly toxic methicillin-resistant Staphylococcus aureus (MRSA) strains (called community-associated [CA] MRSA) appeared in the community. Although the prevalence of HA-MRSA (health-related MRSA) infection remained stable between 1998 and 2008, the CA-MRSA (community-related MRSA) infection rate increased. By far, the most common manifestations of CA-MRSA related diseases are skin and soft tissue infections. Skin and soft tissue infections (SSTIs) account for at least 90% of CA-MRSA infections. CA-MRSA strains also cause bone and joint infections, such as osteomyelitis and respiratory infections, such as pneumonia, sepsis, and urinary tract infections. Given that Staphylococcus aureus can live in the home as a settler or environmental pollutant, the environment can be used as a medium for obtaining and transmitting MRSA. In addition, transmission of MRSA between pets and humans has been proposed, but the directionality is unclear. In this study, we report an in-depth epidemiological and genomics study of a community-associated methicillin-resistant Staphylococcus aureus infection in SSRSH, Zhejiang Province, 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 risk factors for nosocomial or medically related infections, and patients who have been decolonized (using mupirocin, chlorhexidine or bleach) in the past month.
Outcome measures:
- Isolation rate of staphylococcus aureus and methicillin-resistant staphylococcus aureus on domestic environment, contact and pets and livestock.
- Molecular characteristics of CA-MRSA isolates recovered in Chinese hospitals, home environments, contacts, and pets and livestock.
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
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients infected with CA-MRSA | – | Other: none interventionIt is an observational study, no interventions to any of the two study arms. |
| Healthy people without any infection | – | Other: none interventionIt is an observational study, no interventions to any of the two study arms. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- No special requirements
Key inclusion criteria (1 listed)
- Patients (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 risk factors for nosocomial or medically related infections, and patients who have been decolonized (using mupirocin, chlorhexidine or bleach) in the past month.
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 | Other | Healthy people without any infection, Patients infected with CA-MRSA |
Primary outcome
Clonal Distribution of CA-MRSA in China The distribution of sequence types in CA-MRSA isolates from China
Time frame: During the study period (One years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for MRSA
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Does Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes?
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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 MRSA, 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: finished, as of the sponsor's last update on 18 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clonal Distribution of CA-MRSA in China The distribution of sequence types in CA-MRSA isolates from China (time frame: During the study period (One 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 18 Mar 2020.