Osteoarticular TuberculosesNCT04887740
Osteoarticular Infections on Material in Children
An observational study of Osteoarticular Tuberculoses, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The management of osteoarticular infections on equipment is complex. In order to optimize the management of these infections, the French National Authority for Health (HAS) has published good practice recommendations for prosthesis infections in adults. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Osteoarticular Tuberculoses
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 1 Apr 2021
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients under 16 years old hospitalized at the CHU of Montpellier
Who may be able to join
- osteoarticular infections on material in children under 16 years old
- hospitalized at the CHU of Montpellier
Who cannot join
- over 16 years of age
- other types of osteoarticular infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osteoarticular Infections on Material in Children Under 16 Years Old at the CHU of Montpellier From 2014 to 2021
The management of osteoarticular infections on equipment is complex. In order to optimize the management of these infections, the French National Authority for Health (HAS) has published good practice recommendations for prosthesis infections in adults. However, in the pediatric population, this type of infection is rarer and their management less well codified.
The aim of this retrospective and descriptive monocentric study is to identify all osteoarticular infections in children under 16 years of age managed at the Montpellier University Hospital from 2014 to 2021, to study the epidemiology and bacterial ecology of these infections and to evaluate the effectiveness of the therapeutic strategy and side effects, long-term sequels
- Conditions
- Osteoarticular Tuberculoses
- Keywords
- Children
- Medical subject headings
- Tuberculosis, Osteoarticular
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with incidence of osteoarticular infections
To evaluate the incidence of osteoarticular infections on equipment in children under 16 years of age and their medical and surgical management
Measured: day 1
Secondary outcomes (2)
Number of Participants with Epidemiology of osteoarticular infections
To evaluate the Epidemiology of osteoarticular infections on material at the University Hospital of Montpellier
Measured: day 1
Number of Participants with bacterial ecology of osteoarticular infections
To evaluate the bacterial ecology of osteoarticular infections on material at the University Hospital of Montpellier
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start1 Jan 2021
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarticular TuberculosesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Léa DOMITIEN, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887740
- Sponsor's protocol ID
- RECHMPL21_0183
- Status last verified
- May 2021
- First submitted
- 4 May 2021
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoarticular Infections on Material in Children Under 16 Years Old at the CHU of Montpellier From 2014 to 2021
- ClinicalTrials.gov ID
- NCT04887740
- Acronym / sponsor ID
- RECHMPL21_0183
- Conditions
- Osteoarticular Tuberculoses
- Keywords
- Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 14 May 2021 (actual)
- 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 management of osteoarticular infections on equipment is complex. In order to optimize the management of these infections, the French National Authority for Health (HAS) has published good practice recommendations for prosthesis infections in adults. However, in the pediatric population, this type of infection is rarer and their management less well codified.
The aim of this retrospective and descriptive monocentric study is to identify all osteoarticular infections in children under 16 years of age managed at the Montpellier University Hospital from 2014 to 2021, to study the epidemiology and bacterial ecology of these infections and to evaluate the effectiveness of the therapeutic strategy and side effects, long-term sequels
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients under 16 years old hospitalized at the CHU of Montpellier
Key inclusion criteria (2 listed)
- osteoarticular infections on material in children under 16 years old
- hospitalized at the CHU of Montpellier
Key exclusion criteria (2 listed)
- over 16 years of age
- other types of osteoarticular infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with incidence of osteoarticular infections
Time frame: day 1
To evaluate the incidence of osteoarticular infections on equipment in children under 16 years of age and their medical and surgical management
2 secondary outcomes
Number of Participants with Epidemiology of osteoarticular infections
Time frame: day 1
Number of Participants with bacterial ecology of osteoarticular infections
Time frame: day 1
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 21 May 2021.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Osteoarticular Tuberculoses
RecruitingObservational study
Gene Expression Profiles in Spinal Tuberculosis.
Tuberculosis, Spinal, Tuberculosis, Osteoarticular
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.
Léa DOMITIEN principal investigator
University Hospital, Montpellier
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 Osteoarticular Tuberculoses, run by University Hospital, Montpellier 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 2 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 21 May 2021. 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?
Number of Participants with incidence of osteoarticular infections (time frame: day 1). 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 21 May 2021.