- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03852784
Osteoarticular Infections With Pneumococcal
September 21, 2023 updated by: Eugénie MABRUT, Hospices Civils de Lyon
Osteoarticular infections at pneumococcal are rare, potentially serious and remain under diagnosed.
They represent 3 at 10% of the arthritis septic in the literature.
190 cases have been published of 1965 at 2003.
They represent 0.3% at 0.6% of the bacteraemia at Streptococcus peumoniae.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
33
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lyon, France, 69004
- Hospices Civils de Lyon
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
patients having had a bone and joint infection with S pneumoniae, with or without device managed at the Croix-Rousse hospital
Description
Inclusion Criteria:
- patients having had a bone and joint infection with S pneumoniae, with or without device.
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Bone and joint infection with Streptococcus peumoniae
Patients having had an osteoarticular infection with Streptococcus peumoniae
|
description of the osteoarticular infection with Streptococcus peumoniae
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Description and rate of bone or joint infection with S. pneumoniae
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
|
Description of the type of infection due to S. pneumoniae : patients and type of implant, profile of the bacterium associated in the infection, medical and chirurgical treatment
|
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Treatment Failure
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
|
Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin
|
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tristan Ferry, Md,PhD, Hospices Civils de Lyon
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
April 1, 2020
Study Registration Dates
First Submitted
February 21, 2019
First Submitted That Met QC Criteria
February 21, 2019
First Posted (Actual)
February 25, 2019
Study Record Updates
Last Update Posted (Actual)
September 22, 2023
Last Update Submitted That Met QC Criteria
September 21, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-074
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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