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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04625478
Other study ID # 229
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date December 20, 2021

Study information

Verified date January 2022
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Different mechanisms have been proposed to explain the pathophysiology of chronic staphylococcal BJI, including biofilm formation and the ability of staphylococci to be internalized and to survive within cells. The intracellular localization of staphylococci is well documented by in vitro studies, however, few studies have shown the presence of intracellular staphylococci in clinical specimens from patients with BJI. The aim of the CRISBO study is to document the clinical relevance of intracellular staphylococci in the context of BJI. Immunostaining targeting staphylococci and components will be carried out on tissue samples taken from patients with BJI during their treatment (samples similar to those used for routine diagnosis in pathology). Our objectives are to identify whether intracellular staphylococci are observable in these samples and if so, in which cell type (s) are they housed.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 20, 2021
Est. primary completion date September 20, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria: - patients having had an osteo-articular infection with Staphylococci Exclusion Criteria: -

Study Design


Intervention

Other:
Patients having had an osteo-articular infection with Stahylococcus
Immunostaining targeting staphylococci and components will be performed on tissue samples collected from patients with osteo-articular infection

Locations

Country Name City State
France Hospices Civils de Lyon Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary detection of intracellular staphylococci to explore if intracellular staphylococci can be observed on samples of patient having an osteo-articular infection with staphylococci 2 months
Primary rate of localisation of intracellular staphylococci to explore where in what type of celles they can be observed on samples of patient having an osteo-articular infection with staphylococci 2 months
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