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

Methicillin-resistant Staphylococcus Aureus Clinical Trial

Official title:

Community-associated Staphylococcus Aureus Infections in China: Epidemiology, Molecular Characteristics, Treatment, and Outcome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03064464
• Other study ID #: SRRSH-MRSA01
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2017
• Last updated: February 22, 2017
• Start date: December 15, 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: February 2017
• Source: Sir Run Run Shaw Hospital
• Contact: Jian-cang Zhou, MD
• Phone: +86-571-8600-6142
• Email: jiancangzhou[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5400
• Est. completion date: June 30, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Community-Acquired Infections
• Infection
• Methicillin-resistant Staphylococcus Aureus
• Staphylococcal Infections

Intervention

Other:
• None Intervention
It is observational study, no interventios to any of the three study arms

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clonal Distribution of CA-MRSA in China	The distribution of sequence types in CA-MRSA isolates from China	During the study period (Two years)