NCT04312776

Brief 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) 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2020

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

March 16, 2020

Last Update Submit

March 16, 2020

Conditions

Keywords

MRSAWhole-genome sequencing

Outcome Measures

Primary Outcomes (1)

  • Clonal Distribution of CA-MRSA in China The distribution of sequence types in CA-MRSA isolates from China

    During the study period (One years)

Study Arms (2)

Patients infected with CA-MRSA

It is an observational study, no interventions to any of the two study arms.

Other: none intervention

Healthy people without any infection

It is an observational study, no interventions to any of the two study arms.

Other: none intervention

Interventions

Healthy people without any infectionPatients infected with CA-MRSA

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

No special requirements

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Run Run Shaw Hospital

Hanzhou, Zhejiang, 310016, China

Location

Study Officials

  • Yun-song Yu, MD

    Sir Run Run Shaw Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 18, 2020

Study Start

November 15, 2019

Primary Completion

March 17, 2020

Study Completion

March 17, 2020

Last Updated

March 18, 2020

Record last verified: 2020-03

Locations