- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03967210
Epidemiological, Clinical, Microbiological and Outcome Description of Patients With Klebsiella sp Meningitis (KlebsieLCR)
August 20, 2021 updated by: Groupe Hospitalier Paris Saint Joseph
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
132
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brest, France
- CHU Brest
-
Caen, France
- CHU caen
-
Créteil, France
- Hopital Henri Mondor
-
Lyon, France
- CHU Lyon
-
Nantes, France, 44093
- CHU Nantes
-
Nice, France
- CHU Nice
-
Paris, France, 75010
- Hopital Lariboisiere
-
Paris, France
- Hopital Necker Enfants Malades
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Paris, France, 75014
- Hopital Cochin
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Paris, France, 75014
- Groupe Hospitalier Paris Saint-Joseph
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Paris, France
- Hopital Foch
-
Paris, France
- CHU Kremlin Bicêtre
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Paris, France
- Hopital Sainte Anne
-
Poitiers, France, 86000
- CHU Poitiers
-
Reims, France
- CHU Reims
-
Rennes, France, 35000
- CHU Rennes
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Strasbourg, France, 67000
- CHU Strasbourg
-
Tours, France
- Chu Tours
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient with meningitis Klebsiella sp., hospitalized in one of the hospitals of the Clinical Microbiology Group between 2008 and 2018.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patient under tutorship or curatorship
- Patient deprived of liberty
- Patient under safeguard of justice
- Patient opposing his participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Benoit PILMIS, MD, Groupe hospitalier Paris saint Joseph
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 5, 2019
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
January 13, 2020
Study Registration Dates
First Submitted
May 24, 2019
First Submitted That Met QC Criteria
May 29, 2019
First Posted (Actual)
May 30, 2019
Study Record Updates
Last Update Posted (Actual)
August 23, 2021
Last Update Submitted That Met QC Criteria
August 20, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KlebsieLCR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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