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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02812446
Other study ID # RC15_0456
Secondary ID
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


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
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