NCT04625478

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

November 6, 2020

Last Update Submit

December 13, 2025

Conditions

Keywords

Bone and Joint InfectionStaphylococcusintracellulare

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Patients having had an osteo-articular infection with Stahylococcus

Patients having had an osteo-articular infection with Stahylococcus managed at the Croix Rousse hospital

Other: Patients having had an osteo-articular infection with Stahylococcus

Interventions

Immunostaining targeting staphylococci and components will be performed on tissue samples collected from patients with osteo-articular infection

Patients having had an osteo-articular infection with Stahylococcus

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients having had an osteo-articular infection with Staphylococci managed at the Croix-Rousse Hospital

You may qualify if:

  • patients having had an osteo-articular infection with Staphylococci

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

Location

Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 12, 2020

Study Start

December 1, 2020

Primary Completion

September 20, 2021

Study Completion

December 20, 2021

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations