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

Staphylococcal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812446
• Other study ID #: RC15_0456
• Status: Completed
• Phase: N/A
• First received: June 16, 2016
• Last updated: June 23, 2016
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• infected patients with S. Aureus IAI infection

• noninfected patients screened for S. aureus nasal colonization at the orthopedic consultation ward

Exclusion Criteria:

• minor

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Staphylococcal Infection
• Staphylococcal Infections

Intervention

Other:
• IAI infection

• Staphylococcus aureus nasal carriage infection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	biofilm production correlation with genotype	quantile-quantile (QQ)-plot analysis	december 2013	No
Secondary	Correlation between Clonal Complexes distribution , genotype and clinical parameters	In order to determine whether clusters of S. aureus could be associated with clinical characteristics of the patients, search of association between CCs and clinical data was performed	december 2013	No
Secondary	Association of ABO group phenotype and IAI S. aureus genotype	QQ-plots analysis	december 2013	No