MeningitisKlebsieLCRNCT03967210
Epidemiological, Clinical, Microbiological and Outcome Description of Patients With Klebsiella sp Meningitis
An observational study of Meningitis, run by Fondation Hôpital Saint-Joseph at 18 sites in France.
Trial summary
Klebsiella pneumoniae is implicated in the occurrence of severe pneumonia. Most Klebsiella pneumoniae infections are associated with care and occur in patients with compromised immune defenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningitis
- How many people
- 132 participants
- Where
- 18 sitesFrance
- Study dates
- 5 Jul 2019to 13 Jan 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with meningitis Klebsiella sp., hospitalized in one of the hospitals of the Clinical Microbiology Group between 2008 and 2018.
Who may be able to join
- Man or Woman whose age ≥ 18 years
- Patient with meningitis Klebsiella sp., hospitalized in one of the hospitals of the Clinical Microbiology Group
- Francophone patient
Who cannot join
- Patient under tutorship or curatorship
- Patient deprived of liberty
- Patient under safeguard of justice
- Patient opposing his participation
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
CHU Brest
Brest
CHU Caen
Caen
Hôpital henri Mondor
Créteil
CHU Lyon
Lyon
CHU Nantes
Nantes, 44093
CHU Nice
Nice
Hôpital Lariboisière
Paris, 75010
Groupe Hospitalier Paris Saint-Joseph
Paris, 75014
Hôpital Cochin
Paris, 75014
CHU Kremlin Bicetre
Paris
Hôpital Foch
Paris
Hôpital Necker Enfants Malades
Paris
Hôpital Sainte Anne
Paris
CHU Poitiers
Poitiers, 86000
CHU Reims
Reims
CHU Rennes
Rennes, 35000
CHU Strasbourg
Strasbourg, 67000
CHU Tours
Tours
About this study
Klebsiella pneumoniae is implicated in the occurrence of severe pneumonia. Most Klebsiella pneumoniae infections are associated with care and occur in patients with compromised immune defenses. More recently, cases of hepatic abscess and acute community meningitis related to strains of Klebsiella pneumoniae have been reported. The mortality of these infections is important, most often due to a delayed diagnosis. The poor prognostic factors reported in the literature for very low numbers are: advanced age, coma, septic shock, glyceryachia <10mg / dL and proteinuria> 750 mg / dL. In addition, no study has specifically focused on the factors of occurrence and factors associated with Klebsiella sp. Indeed, meningitis related to Klebsiella pneumoniae seems to be a rare but probably underestimated event whose risk factors, clinical presentation, microbiological are little known and the treatment modalities of this severe infection are not codified.
- Conditions
- Meningitis
- Medical subject headings
- Meningitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize meningitis with Klebsiella pneumoniae
This corresponds to characterize Klebsiella pneumoniae meningitis, portal entry, secondary infection, associated antibiotic and associated therapies and the clinical course of patients.
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 posted30 May 2019
- Study start5 Jul 2019
- Primary completion31 Dec 2019
- Study completion13 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningitisStudies of the same condition, open and under way.
- 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit PILMIS, MD, Study director, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967210
- Sponsor's protocol ID
- KlebsieLCR
- Acronym
- KlebsieLCR
- Status last verified
- Aug 2021
- First submitted
- 24 May 2019
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological, Clinical, Microbiological and Outcome Description of Patients With Klebsiella sp Meningitis
- ClinicalTrials.gov ID
- NCT03967210
- Acronym / sponsor ID
- KlebsieLCR / KlebsieLCR
- Conditions
- Meningitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 13 Jan 2020 (actual)
- First posted
- 30 May 2019 (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.
Klebsiella pneumoniae is implicated in the occurrence of severe pneumonia. Most Klebsiella pneumoniae infections are associated with care and occur in patients with compromised immune defenses. More recently, cases of hepatic abscess and acute community meningitis related to strains of Klebsiella pneumoniae have been reported. The mortality of these infections is important, most often due to a delayed diagnosis. The poor prognostic factors reported in the literature for very low numbers are: advanced age, coma, septic shock, glyceryachia <10mg / dL and proteinuria> 750 mg / dL. In addition, no study has specifically focused on the factors of occurrence and factors associated with Klebsiella sp. Indeed, meningitis related to Klebsiella pneumoniae seems to be a rare but probably underestimated event whose risk factors, clinical presentation, microbiological are little known and the treatment modalities of this severe infection are not codified.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with meningitis Klebsiella sp., hospitalized in one of the hospitals of the Clinical Microbiology Group between 2008 and 2018.
Key inclusion criteria (3 listed)
- Man or Woman whose age ≥ 18 years
- Patient with meningitis Klebsiella sp., hospitalized in one of the hospitals of the Clinical Microbiology Group
- Francophone patient
Key exclusion criteria (4 listed)
- Patient under tutorship or curatorship
- Patient deprived of liberty
- Patient under safeguard of justice
- Patient opposing his participation
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
Characterize meningitis with Klebsiella pneumoniae
Time frame: Day 1
This corresponds to characterize Klebsiella pneumoniae meningitis, portal entry, secondary infection, associated antibiotic and associated therapies and the clinical course of patients.
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 23 Aug 2021.
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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.
Benoit PILMIS, MD study director
Fondation Hôpital Saint-Joseph
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningitis, run by Fondation Hôpital Saint-Joseph at 18 sites 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 3 inclusion and 4 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 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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?
Characterize meningitis with Klebsiella pneumoniae (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 23 Aug 2021.