Bacterial MeningitisNCT03595761
Meningitis With Cerebral Vasculitis in Children
An observational study of Bacterial Meningitis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Purulent meningitis are life-threatening diseases in childhood. Cerebral vasculitis have been described in bacterial meningitis, but poor is known about their physiology and their impact on outcome. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Bacterial Meningitis
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2017to 31 Aug 2017
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with bacterial meningitis, and cerrbal vasculitis
Who may be able to join
- bacterial meningitis with LCR confirmation
Who cannot join
- tuberculous meningitis, immunosuppressor treatment, material like DVP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Study About 17 Cases of Child With Bacterial Meningitis Coupled With Cerebral Vasculitis
Purulent meningitis are life-threatening diseases in childhood. Cerebral vasculitis have been described in bacterial meningitis, but poor is known about their physiology and their impact on outcome.
The investigators decide to realize a retrospective mono-centric study carried out at Montpellier university hospital which looks back at a 7-year study(2009-2016).
Read more
The Investigators selected purulent meningitis cases based on the bacteriological data provided by the HDB (hospital data base). The Investigators divides in two groups : Group A if patients present a cerebral vasculitis ( radiologic diagnostic by RMI or tomodensitometry), in all, cases the diagnosis of vasculitis was confirmed by a radiologist specialised in neuropaediatrics by a second reading;Group B purulent meningitis with a cerebral vasculitis imaging.
Tuberculous meningitis, meningitis in CSF shunt, and in patients having chemotherapy were excluded.
The investigators report clinical and biological finding, inflammatory marker at the onset. The Investigators register also the clinical evolution and sequelae
Read the detailed description
Meningitis steel are a cause of death in childhood. Cerebral complication are often responsable of poor prognosis. One of these complication vasculitis is steel not weel understood. There are only few study about it on children.
It is a retrospective study about 17 cases of chil which bacterial meningitis coupled wiethe cerebral vasculitis, the Investigators will describe epidemiology, bacteriology, evolution and corticosteroid treatment in this patients.
- Conditions
- Bacterial Meningitis
- Keywords
- cerebral vasculitis
- Medical subject headings
- Meningitis, Bacterial, Vasculitis, Central Nervous System
What is being measured
The primary outcome is the main question the study is designed to answer.
Found a difference demographic data
Found a difference demographic data between population A and B (age)
Measured: 1 day
Found a difference demographic data
Found a difference demographic data between population A and B (gender)
Measured: 1 day
Found a difference Clinical manifestation
Found a difference Clinical manifestation between population A and B
Measured: 1 day
Found a difference Inflammatory parkers
Found a difference Inflammatory parkers between population A and B
Measured: 1 day
Found a difference Infectious agent
Found a difference Infectious agent between population A and B
Measured: 1 day
Secondary outcomes (2)
Found a difference in the evolution of the diseases between group A and B
The data analysed will be : presence of seizure within the next 6 month before the last survey, necessity of antiepileptic treatment, development delay, presence of neurologic deficiency(palsy), persistence of abnormality on neuroimaging.
Measured: 1 day
In the A group, studying the relationship between prescription of steroids pulse and final outcome and presence of sequelae.
Sequelae will be defined by the presence of one of this element : : presence of seizure within the next 6 month before the last survey, necessity of antiepileptic treatment, development delay, presence of neurologic deficiency(palsy), persistence of abnormality on neuroimaging.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start1 Jun 2017
- Primary completion1 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial MeningitisStudies 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric JEZIORSKI, Study director, UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595761
- Sponsor's protocol ID
- RECHMPL17_0193
- Status last verified
- Jul 2017
- First submitted
- 6 Jul 2017
- Last updated
- 26 Jul 2018
- 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 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study About 17 Cases of Child With Bacterial Meningitis Coupled With Cerebral Vasculitis
- ClinicalTrials.gov ID
- NCT03595761
- Acronym / sponsor ID
- RECHMPL17_0193
- Conditions
- Bacterial Meningitis
- Keywords
- cerebral vasculitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 23 Jul 2018 (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.
Purulent meningitis are life-threatening diseases in childhood. Cerebral vasculitis have been described in bacterial meningitis, but poor is known about their physiology and their impact on outcome.
The investigators decide to realize a retrospective mono-centric study carried out at Montpellier university hospital which looks back at a 7-year study(2009-2016).
The Investigators selected purulent meningitis cases based on the bacteriological data provided by the HDB (hospital data base). The Investigators divides in two groups : Group A if patients present a cerebral vasculitis ( radiologic diagnostic by RMI or tomodensitometry), in all, cases the diagnosis of vasculitis was confirmed by a radiologist specialised in neuropaediatrics by a second reading;Group B purulent meningitis with a cerebral vasculitis imaging.
Tuberculous meningitis, meningitis in CSF shunt, and in patients having chemotherapy were excluded.
The investigators report clinical and biological finding, inflammatory marker at the onset. The Investigators register also the clinical evolution and sequelae
Detailed description
Meningitis steel are a cause of death in childhood. Cerebral complication are often responsable of poor prognosis. One of these complication vasculitis is steel not weel understood. There are only few study about it on children.
It is a retrospective study about 17 cases of chil which bacterial meningitis coupled wiethe cerebral vasculitis, the Investigators will describe epidemiology, bacteriology, evolution and corticosteroid treatment in this patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with bacterial meningitis, and cerrbal vasculitis
Key inclusion criteria (1 listed)
- bacterial meningitis with LCR confirmation
Key exclusion criteria (1 listed)
- tuberculous meningitis, immunosuppressor treatment, material like DVP
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
Found a difference demographic data
Time frame: 1 day
Found a difference demographic data between population A and B (age)
Found a difference demographic data
Time frame: 1 day
Found a difference demographic data between population A and B (gender)
Found a difference Clinical manifestation
Time frame: 1 day
Found a difference Clinical manifestation between population A and B
Found a difference Inflammatory parkers
Time frame: 1 day
Found a difference Inflammatory parkers between population A and B
Found a difference Infectious agent
Time frame: 1 day
Found a difference Infectious agent between population A and B
2 secondary outcomes
Found a difference in the evolution of the diseases between group A and B
Time frame: 1 day
In the A group, studying the relationship between prescription of steroids pulse and final outcome and presence of sequelae.
Time frame: 1 day
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 26 Jul 2018.
- Individual participant dataSharing planned: Undecided. NC
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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.
Eric JEZIORSKI study director
UH
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 Bacterial Meningitis, 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 1 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 26 Jul 2018. 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?
Found a difference demographic data (time frame: 1 day). The study lists 5 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 26 Jul 2018; AzTrials last refreshed its copy on 1 Nov 2026.