CA-MRSA Infection in China: Epidemiology, Molecular Characteristics, Treatment, and Outcome

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.

Study Overview

• Status: Unknown
• Conditions: Methicillin-resistant Staphylococcus Aureus; Community-Acquired Infections
• Intervention / Treatment: Other: None Intervention

Detailed Description

Eligibility criteria:

1. 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.
2. Exclusion criteria: Patients with S. aureus from anterior nares or throat swabs cultures (colonization).

Outcome measures:

1. Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) infection rates in patients with S. aureus infections in Chinese hospitals.
2. Risk factors and clinical outcomes of CA-MRSA infection
3. 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 Type: Observational
• Enrollment (Anticipated): 5400

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Recruiting
      • Sir Run Run Shaw Hospital
      • Contact: Ying-zhi Fang; Phone Number: +86 571 86006987
      • Principal Investigator: Yun-song Yu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

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 for colonization screening purpose.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CA-MRSA infection; None intervention	Other: None Intervention; It is observational study, no interventios to any of the three study arms
HA-MRSA infection; None intervention	Other: None Intervention; It is observational study, no interventios to any of the three study arms
CA-MSSA infection; None intervention	Other: None Intervention; It is observational study, no interventios to any of the three study arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clonal Distribution of CA-MRSA in China	The distribution of sequence types in CA-MRSA isolates from China	During the study period (Two years)

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital
• Investigators: Principal Investigator: Yun-song Yu, MD, Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2016
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): June 30, 2018

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (Actual): February 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: methicillin-resistant Staphylococcus aureus
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Staphylococcal Infections; Community-Acquired Infections
• Other Study ID Numbers: SRRSH-MRSA01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No