Community-based MeningitisMENINGITENCT02868593
Etiology of Orphan Community-based Meningitis and Meningo-encephalitis.
A study testing Pharyngeal swab in people with Community-based Meningitis and Meningo-encephalitis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The primary purpose of this study is to assess the contribution of a non-invasive sampling (pharyngeal swab) in the diagnosis of community based meningitis or meningo-encephalitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-based Meningitis, Meningo-encephalitis
- What is being tested?
- Pharyngeal swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Jun 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is aged more than 18 years old.
- Patient with clinical meningitis or meningo-encephalitis with community transmission.
- Patient with a prescription of microbiological diagnosis of meningitis or meningo-encephalitis.
- Patient who do not declined to have his medical records reviewed for research
- Patient with health insurance
Who cannot join
- Minor Patient (age <18 years)
- Pregnant woman, parturient or breastfeeding
- Adult Patient under guardianship
- Patient deprived of liberty under court order
- Patient vital in emergency.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille
MICHEL DRANCOURT, michel.drancourt@ap-hm.fr
About this study
The primary purpose of this study is to assess the contribution of a non-invasive sampling (pharyngeal swab) in the diagnosis of community based meningitis or meningo-encephalitis.
Read the detailed description
Community-based meningitis and meningo-encephalitis are defined by the presence of more than 10 leukocytes per mL of cerebrospinal fluid (CSF), eventually reported to the number of red blood cells. They can be associated with encephalitis, defined by cerebral or cerebellar dysfunction in the case of the transmission. The evolution includes death, what makes the seriousness of this clinical situation. However the diagnostic performance of meningitis and meningo-encephalitis in a patient without contact with a care structure is less than 25% resulting in empirical support in half of the patients. Indeed, the microbiological diagnosis of meningitis and transmission target currently only five pathogens including HIV positive resulted in a significant change to support the patient in three areas, decision of hospitalization, decision of isolation and antibiotic or antiviral treatment decision. A weekly epidemiological monitoring of the microbiological diagnosis of meningitis and meningo-encephalitis has enabled us to see a mismatch between a curve of requests for analyses and a flat curve of produced diagnoses. This discrepancy is interpreted as indicating a community outbreak of meningitis or meningo-encephalitis non-diagnosed by routine methods, called orphan meningitis or orphan meningo-encephalitis. On this observation, our research project is to improve the performance of the etiological diagnosis of community-based meningitis or meningo-encephalitis. To do this, we will evaluate the diagnostic performance of an advanced technique, using a non-invasive sample, the pharyngeal swab from the patient, to find micro-organisms that are not part of the commensal flora of the pharynx and who are responsible for undetected in routine meningitis. Indeed the main pathogens and meningitis (enterovirus, pneumococcus, meningococcus) transmission give a pharyngeal carriage before being responsible for meningitis or meningo-encephalitis. These bacteria are Coxiella burnetii, Bartonella spp., Tropheryma whipplei, Leptospira spp. and Borrelia spp.
- Conditions
- Community-based Meningitis, Meningo-encephalitis
- Being tested
- Pharyngeal swab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharyngeal swabOther
| Study group | Role | What they receive |
|---|---|---|
| Patient with clinical meningitis or meningo-encephalitis | Experimental | Not described Receives: Other: Pharyngeal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with established etiological diagnosis of community based meningitis or meningo-encephalitis
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 posted16 Aug 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-based MeningitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine GEINDRE, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868593
- Sponsor's protocol ID
- 2013-47
- Other IDs
- 2013-A01538-37
- Acronym
- MENINGITE
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiology of Orphan Community-based Meningitis and Meningo-encephalitis.
- ClinicalTrials.gov ID
- NCT02868593
- Acronym / sponsor ID
- MENINGITE / 2013-47
- Conditions
- Community-based Meningitis, Meningo-encephalitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 16 Aug 2016 (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 primary purpose of this study is to assess the contribution of a non-invasive sampling (pharyngeal swab) in the diagnosis of community based meningitis or meningo-encephalitis.
Detailed description
Community-based meningitis and meningo-encephalitis are defined by the presence of more than 10 leukocytes per mL of cerebrospinal fluid (CSF), eventually reported to the number of red blood cells. They can be associated with encephalitis, defined by cerebral or cerebellar dysfunction in the case of the transmission. The evolution includes death, what makes the seriousness of this clinical situation. However the diagnostic performance of meningitis and meningo-encephalitis in a patient without contact with a care structure is less than 25% resulting in empirical support in half of the patients. Indeed, the microbiological diagnosis of meningitis and transmission target currently only five pathogens including HIV positive resulted in a significant change to support the patient in three areas, decision of hospitalization, decision of isolation and antibiotic or antiviral treatment decision. A weekly epidemiological monitoring of the microbiological diagnosis of meningitis and meningo-encephalitis has enabled us to see a mismatch between a curve of requests for analyses and a flat curve of produced diagnoses. This discrepancy is interpreted as indicating a community outbreak of meningitis or meningo-encephalitis non-diagnosed by routine methods, called orphan meningitis or orphan meningo-encephalitis. On this observation, our research project is to improve the performance of the etiological diagnosis of community-based meningitis or meningo-encephalitis. To do this, we will evaluate the diagnostic performance of an advanced technique, using a non-invasive sample, the pharyngeal swab from the patient, to find micro-organisms that are not part of the commensal flora of the pharynx and who are responsible for undetected in routine meningitis. Indeed the main pathogens and meningitis (enterovirus, pneumococcus, meningococcus) transmission give a pharyngeal carriage before being responsible for meningitis or meningo-encephalitis. These bacteria are Coxiella burnetii, Bartonella spp., Tropheryma whipplei, Leptospira spp. and Borrelia spp.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with clinical meningitis or meningo-encephalitis | Experimental | Other: Pharyngeal swab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is aged more than 18 years old.
- Patient with clinical meningitis or meningo-encephalitis with community transmission.
- Patient with a prescription of microbiological diagnosis of meningitis or meningo-encephalitis.
- Patient who do not declined to have his medical records reviewed for research
- Patient with health insurance
Key exclusion criteria (5 listed)
- Minor Patient (age <18 years)
- Pregnant woman, parturient or breastfeeding
- Adult Patient under guardianship
- Patient deprived of liberty under court order
- Patient vital in emergency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharyngeal swab | Other | Patient with clinical meningitis or meningo-encephalitis |
Primary outcome
Percentage of patients with established etiological diagnosis of community based meningitis or meningo-encephalitis
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Community-based Meningitis
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
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.
Catherine GEINDRE study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharyngeal swab in people with Community-based Meningitis and Meningo-encephalitis, run by Assistance Publique Hopitaux De Marseille 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Aug 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel DRANCOURT (04 91 38 55 19 ext. +33, michel.drancourt@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with established etiological diagnosis of community based meningitis or meningo-encephalitis (time frame: 1 day). 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 16 Aug 2016.