Staphylococcal InfectionNCT02812446
Staphylokinase and ABO Group Phenotype: New Players in Staphylococcus Aureus Implant-associated Infections Development
An observational study of Staphylococcal Infection, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Staphylococcal Infection
- What is being tested?
- IAI infection and Staphylococcus aureus nasal carriage infection
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- infected patients with S. Aureus IAI infection
- noninfected patients screened for S. aureus nasal colonization at the orthopedic consultation ward
Who cannot join
- minor
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- IAI infection, Staphylococcus aureus nasal carriage infection
- Keywords
- biofilm, staphylokinase, Staphylococcus aureus, microarrays, bone binding sialoprotein, bone and joint infection, blood group
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IAI infectionOther
Staphylococcus aureus nasal carriage infectionOther
| Study group | Role | What they receive |
|---|---|---|
| IAI patients group | patients with Staphylococcus aureus of implant-associated infections Receives: Other: IAI infection | |
| control group | patients with Staphylococcus aureus nasal carriage Receives: Other: Staphylococcus aureus nasal carriage infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: september 2012
Secondary outcomes (3)
biofilm production correlation with genotype
quantile-quantile (QQ)-plot analysis
Measured: december 2013
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
Measured: december 2013
Association of ABO group phenotype and IAI S. aureus genotype
QQ-plots analysis
Measured: december 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startFeb 2012
- Primary completionSep 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcal InfectionStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812446
- Sponsor's protocol ID
- RC15_0456
- Status last verified
- Jun 2016
- First submitted
- 16 Jun 2016
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staphylokinase and ABO Group Phenotype: New Players in Staphylococcus Aureus Implant-associated Infections Development
- ClinicalTrials.gov ID
- NCT02812446
- Acronym / sponsor ID
- RC15_0456
- Conditions
- Staphylococcal Infection
- Keywords
- biofilm, staphylokinase, Staphylococcus aureus, microarrays, bone binding sialoprotein, bone and joint infection, blood group
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IAI patients group | – | Other: IAI infectionpatients with Staphylococcus aureus of implant-associated infections |
| control group | – | Other: Staphylococcus aureus nasal carriage infectionpatients with Staphylococcus aureus nasal carriage |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- infected patients with S. Aureus IAI infection
- noninfected patients screened for S. aureus nasal colonization at the orthopedic consultation ward
Key exclusion criteria (1 listed)
- minor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IAI infection | Other | IAI patients group |
| Staphylococcus aureus nasal carriage infection | Other | control group |
Primary outcome
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
3 secondary outcomes
biofilm production correlation with genotype
Time frame: december 2013
Correlation between Clonal Complexes distribution , genotype and clinical parameters
Time frame: december 2013
Association of ABO group phenotype and IAI S. aureus genotype
Time frame: december 2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcal Infection, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biofilm production measurement in the two groups (time frame: september 2012). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.