NCT03967210

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

July 5, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2020

Completed
Last Updated

August 23, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

May 24, 2019

Last Update Submit

August 20, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with meningitis Klebsiella sp., hospitalized in one of the hospitals of the Clinical Microbiology Group between 2008 and 2018.

You may qualify if:

  • 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

You may not qualify if:

  • Patient under tutorship or curatorship
  • Patient deprived of liberty
  • Patient under safeguard of justice
  • Patient opposing his participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

CHU Brest

Brest, France

Location

CHU Caen

Caen, France

Location

Hôpital henri Mondor

Créteil, France

Location

CHU Lyon

Lyon, France

Location

CHU Nantes

Nantes, 44093, France

Location

CHU Nice

Nice, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Hôpital Cochin

Paris, 75014, France

Location

CHU Kremlin Bicetre

Paris, France

Location

Hôpital Foch

Paris, France

Location

Hôpital Necker Enfants Malades

Paris, France

Location

Hôpital Sainte Anne

Paris, France

Location

CHU Poitiers

Poitiers, 86000, France

Location

CHU Reims

Reims, France

Location

CHU Rennes

Rennes, 35000, France

Location

CHU Strasbourg

Strasbourg, 67000, France

Location

CHU Tours

Tours, France

Location

MeSH Terms

Conditions

Meningitis

Condition Hierarchy (Ancestors)

Neuroinflammatory DiseasesNervous System Diseases

Study Officials

  • Benoit PILMIS, MD

    Fondation Hôpital Saint-Joseph

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2019

First Posted

May 30, 2019

Study Start

July 5, 2019

Primary Completion

December 31, 2019

Study Completion

January 13, 2020

Last Updated

August 23, 2021

Record last verified: 2021-08

Locations