NCT03064464

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

December 15, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

February 22, 2017

Last Update Submit

February 22, 2017

Conditions

Keywords

methicillin-resistant Staphylococcus aureus

Outcome Measures

Primary Outcomes (1)

  • 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

    During the study period (Two years)

Secondary Outcomes (1)

  • Clonal Distribution of CA-MRSA in China

    During the study period (Two years)

Study Arms (3)

CA-MRSA infection

None intervention

Other: None Intervention

HA-MRSA infection

None intervention

Other: None Intervention

CA-MSSA infection

None intervention

Other: None Intervention

Interventions

It is observational study, no interventios to any of the three study arms

CA-MRSA infectionCA-MSSA infectionHA-MRSA infection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All child and adult patients with Staphylococcus aureus visited any of the 60 particitant hospitals during the study period were included.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with S. aureus from anterior nares or throat swabs cultures for colonization screening purpose.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

bacterial isolates

MeSH Terms

Conditions

Community-Acquired Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Yun-song Yu, MD

    Sir Run Run Shaw Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Infectious Diseases

Study Record Dates

First Submitted

February 22, 2017

First Posted

February 27, 2017

Study Start

December 15, 2016

Primary Completion

December 31, 2017

Study Completion

June 30, 2018

Last Updated

February 27, 2017

Record last verified: 2017-02

Locations