Staphylokinase and ABO Group Phenotype: New Players in Staphylococcus Aureus Implant-associated Infections Development

NCT02812446 | Completed

• 1 other identifier: RC15_0456
• Study Type: observational
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to identify bacterial and/or clinical features involved in the pathogenesis of Staphylococcus aureus implant-associated infections (IAI). Materials \& methods: In total, 57 IAI S. aureus and 31 nasal carriage (NC) S. aureus isolates were studied. Staphylococcus aureus genetic background was obtained by microarray analysis. Multilocus sequence typing was performed to determine clonal complexes (CC). Biofilm production was investigated by resazurin and crystal violet methods

Conditions

Staphylococcal Infection

Keywords

biofilm; staphylokinase; Staphylococcus aureus; microarrays; bone binding sialoprotein; bone and joint infection; blood group

Outcome Measures

Primary Outcomes (3)

• biofilm production measurement in the two groups

  The primary aim of this study is to identify phenotypic (biofilm production) markers in two different groups of S. aureus strains isolated from patients with IAI or screened from nasal carrier in noninfected patients undergoing orthopedic surgery. By using resazurin method, IAI and NC nasal carriage isolates were divided into three groups. Isolates were classified as strong, moderate and weak biofilm producers.

  september 2012

• Clonal complexes distribution

  The primary aim of this study is to identify genotypic markers in two different groups of S. aureus strains isolated from patients with IAI or screened from nasal carrier in noninfected patients undergoing orthopedic surgery. IAI and NC isolates genetic background was determined in order to compare the prevalence of individual virulence factor genes. All genes provided by the Alere StaphyType DNA microarray were studied.

  september 2012

• IAI and NC nasal carriage isolates genetic background

  IAI and NC isolates genetic background was determined in order to compare the prevalence of individual virulence factor genes. All genes provided by the Alere StaphyType DNA microarray were studied

  september 2012

Secondary Outcomes (3)

• biofilm production correlation with genotype

  december 2013

• Correlation between Clonal Complexes distribution , genotype and clinical parameters

  december 2013

• Association of ABO group phenotype and IAI S. aureus genotype

  december 2013

Study Arms (2)

IAI patients group

patients with Staphylococcus aureus of implant-associated infections

Other: IAI infection

control group

patients with Staphylococcus aureus nasal carriage

Other: Staphylococcus aureus nasal carriage infection

Interventions

IAI infection OTHER

IAI patients group

Staphylococcus aureus nasal carriage infection OTHER

control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Fifty-five IAI patients were included; two of them had two different S. aureus IAI episodes. The median age was 73 years (range: 21-96 years) with 29 women (52.7%). Twenty seven percent of patients suffered from diabetes and were smokers. Nine patients including six women were immunosuppressed with a median age of 71 years. The main diagnosis for arthroplasty was arthrosis (38%). Implants were hip prosthesis (n = 35), knee prosthesis (n = 18) and osteosynthesis (n = 4). Main local consequences of IAI were scarce alteration (n = 34) and skin fistulization (n = 22). These IAI were treated by surgical removal of all infected tissue and implant or a combination of debridement with implant retention associated to long-term antimicrobial therapy active against biofilm microorganisms. Eighteen early, nine delayed and 30 late infections occurred. Blood group phenotypes were available for 54 patients and were distributed as follows: 26 O group, 17 A group, 10 B group and one AB group.

You may qualify if:

• infected patients with S. Aureus IAI infection
• noninfected patients screened for S. aureus nasal colonization at the orthopedic consultation ward

You may not qualify if:

• minor

Sponsors & Collaborators

• Nantes University Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

A total of 57 nonduplicate S. aureus clinical isolates collected from implant-associated infections (IAI) between January 2007 and December 2010 at Nantes University Hospital (France) were analyzed. IAI were confirmed using Infectious Diseases Society of America criteria for bone and joint infections. Thirty-five isolates came from hip arthroplasty, 18 from knee replacement and four from osteosynthesis. Thirty-one S. aureus isolates were collected from 100 noninfected patients screened for S. aureus nasal colonization from December 2011 to February 2012 at the orthopedic consultation ward.

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 24, 2016
• Study Start: February 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2013
• Last Updated: June 24, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share