We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 58 of 23945 for:    "Communicable Diseases"

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02812446
First Posted: June 24, 2016
Last Update Posted: June 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nantes University Hospital
  Purpose
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

Condition Intervention
Staphylococcal Infection Other: IAI infection Other: Staphylococcus aureus nasal carriage infection

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Staphylokinase and ABO Group Phenotype: New Players in Staphylococcus Aureus Implant-associated Infections Development

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • biofilm production measurement in the two groups [ Time Frame: september 2012 ]

    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.


  • Clonal complexes distribution [ Time Frame: september 2012 ]

    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.


  • IAI and NC nasal carriage isolates genetic background [ Time Frame: september 2012 ]
    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


Secondary Outcome Measures:
  • biofilm production correlation with genotype [ Time Frame: december 2013 ]
    quantile-quantile (QQ)-plot analysis

  • Correlation between Clonal Complexes distribution , genotype and clinical parameters [ Time Frame: december 2013 ]
    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

  • Association of ABO group phenotype and IAI S. aureus genotype [ Time Frame: december 2013 ]
    QQ-plots analysis


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.

Enrollment: 88
Study Start Date: February 2012
Study Completion Date: December 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02812446     History of Changes
Other Study ID Numbers: RC15_0456
First Submitted: June 16, 2016
First Posted: June 24, 2016
Last Update Posted: June 24, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nantes University Hospital:
biofilm
staphylokinase
Staphylococcus aureus
microarrays
bone binding sialoprotein
bone and joint infection
blood group

Additional relevant MeSH terms:
Infection
Communicable Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections