Trial document





This trial has been registered retrospectively.
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  DRKS00017576

Trial Description

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Title

MENINT-Register - Prospective register of patients with bacterial meningitis at intensive care units in Germany

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Trial Acronym

MENINT

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URL of the Trial

https://www.dgni.de/forschung/ignite-initiative-klinischer-multizenter-studien/aktuelle-projekte/54-inflammatorische-und-infektiologische-erkrankungen/625-menint-register.html

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Brief Summary in Lay Language

A prospective, national register for bacterial meningitis at intensive care units in Germany is being established. One focus of the study is the acquisition of data on clinical symptoms, physical examination, laboratory and technical diagnostics in the early stage of the disease. Additionally, our study systematically analyses the incidence of complications, specific therapeutic approaches and the influence on the course of the disease. A follow-up survey aims at evaluating long-term outcome. Data is collected via case report forms at local study centres and transferred to the coordinating centre at the LMU Munich.

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Brief Summary in Scientific Language

Incidence and mortality of bacterial meningitis decreased during the last years as a result of vaccination programmes and improved therapies. However, in pneumococcal meningitis, the most frequent form of community acquired meningitis, mortality is still about 10-15% and up to 50% of patients suffer from permanent neurological deficits. A prospective, national register for bacterial meningitis at intensive care units in Germany is being established. One focus of the study is the acquisition of data on clinical symptoms, physical examination, laboratory and technical diagnostics in the early stage of the disease. Additionally, our study systematically analyses the incidence of complications, specific therapeutic approaches and their influence on the course of the disease. Furthermore, the long-term outcome is evaluated by a follow-up survey 6-12 months after hospital discharge. Therefore, relevant functions for everyday life and meningitis-associated complications like hearing loss, cognitive deficits and neurological defects are recorded. In the MENINT-register data is collected via case report forms at local study centres and transferred to the coordinating centre at the LMU Munich. A follow-up survey after 6-12 months aims at evaluating long-term outcome.

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Organizational Data

  •   DRKS00017576
  •   2019/07/22
  •   [---]*
  •   yes
  •   Approved
  •   17-597, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G00 -  Bacterial meningitis, not elsewhere classified
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Interventions/Observational Groups

  •   A prospective, national register for bacterial meningitis at intensive care units in Germany is being established. One focus of the study is the acquisition of data on clinical symptoms, physical examination, laboratory and technical diagnostics in the early stage of the disease. Additionally, our study systematically analyses the incidence of complications, specific therapeutic approaches and the influence on the course of the disease. A follow-up survey after 6-12 months aims at evaluating long-term outcome. Data is collected via case report forms at local study centres and transferred to the coordinating centre at the LMU Munich.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Prospective analysis of data from patients with bacterial meningitis in Germany during hospital stay and 6-12 months after discharge.

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/11/01
  •   250
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

diagnosis of community acquired bacterial meningitis (detection of pathogen in cerebrospinal fluid; alternatively cell count >1000/µl, protein >100 mg/dl and liquor/serum glucose <0,3 or lactate >3,5 mmol/l)

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Exclusion Criteria

age <18 years, hospital-acquired meningitis

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Addresses

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    • Neurologische Klinik und Poliklinik, Klinikum der LMU München - Großhadern
    • Mr.  Prof. Dr. med.  Matthias  Klein 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Neurologische Klinik und Poliklinik, Klinikum der LMU München - Großhadern
    • Mr.  Prof. Dr. med.  Matthias  Klein 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Neurologische Klinik und Poliklinik, Klinikum der LMU München - Großhadern
    • Ms.  Dr. med.  Stefanie  Völk 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Neurologische Klinik und Poliklinik
    • 81377  München
    • Germany
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    •   [---]*
    •   [---]*
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    • Deutsche Gesellschaft für Neurointensiv- und Notfallmedizin
    • 07745  Jena
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.