Meningococcal InfectionsNCT00450632
Creation of a Biotheque of Patients of Seine-Maritime With Meningococcal Infection
An observational study of Meningococcal Infections, run by University Hospital, Rouen at 1 site in France.
Trial summary
The main objective of this study is to constitute a biotheque of patients with meningococcal disease to enable results to be interpreted and genetic factors to be determined Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Meningococcal Infections
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2005to Jan 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects of Seine-Maritime with a meningococcal disease
Who may be able to join
- Subjects of Seine-Maritime with a meningococcal disease from the year of 2000
- parental authority assent if necessary
Who cannot join
- no parental authority assent
- child under supervision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CONSTITUTION D'UNE BIOTHEQUE DE PATIENTS DE SEINE-MARITIME AUX ANTECEDENTS D'INFECTION INVASIVE A MENINGOCOQUES
The main objective of this study is to constitute a biotheque of patients with meningococcal disease to enable results to be interpreted and genetic factors to be determined
- Conditions
- Meningococcal Infections
- Keywords
- meningococcal infections, biotheque, genetic markers
- Medical subject headings
- Meningococcal Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2007 (estimated)
- Study startSep 2005
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningococcal InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Caron, Professor, Principal investigator, University Hopital of Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450632
- Sponsor's protocol ID
- 2005/031/HP
- Status last verified
- Mar 2012
- First submitted
- 21 Mar 2007
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONSTITUTION D'UNE BIOTHEQUE DE PATIENTS DE SEINE-MARITIME AUX ANTECEDENTS D'INFECTION INVASIVE A MENINGOCOQUES
- ClinicalTrials.gov ID
- NCT00450632
- Acronym / sponsor ID
- 2005/031/HP
- Conditions
- Meningococcal Infections
- Keywords
- meningococcal infections, biotheque, genetic markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 22 Mar 2007 (estimated)
- 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 main objective of this study is to constitute a biotheque of patients with meningococcal disease to enable results to be interpreted and genetic factors to be determined
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects of Seine-Maritime with a meningococcal disease
Key inclusion criteria (2 listed)
- Subjects of Seine-Maritime with a meningococcal disease from the year of 2000
- parental authority assent if necessary
Key exclusion criteria (2 listed)
- no parental authority assent
- child under supervision
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
Not reported in the source record.
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 27 Mar 2012.
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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.
François Caron, Professor principal investigator
University Hopital of Rouen
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 Meningococcal Infections, run by University Hospital, Rouen 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 27 Mar 2012. 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.
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 27 Mar 2012.