Trial document




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  DRKS00004178

Trial Description

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Title

Identification of microbes through detection of pathogen specific volatile compound patterns, using multi-capillary column coupled ion mobility spectrometry (MCC-IMS) in the setting of hospital-acquired pneumonia.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

With this study it is to be investigated, if a fast identification of germs, causing hospital acquired infections of the lower respiratory tract, is possible through the use of MCC-IMS technology (multi-capillary column coupled ion mobility spectrometry) - a method that allows on time detection and identification of very small amounts of substances in gas samples. Therefore aspiration samples from the respiratory tracts of ventilated patients, which are suspected to develop such an infection, will be collected, cultivated and analyzed by MCC-IMS. We want to investigate if MCC-IMS diagnostic could be a faster alternative to conventional microbiological methods. The results of the MCC-IMS analyses therefore will be compared with results of conventional microbiological methods.

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Brief Summary in Scientific Language

In this clinical feasibility study we want to investigate if MCC-IMS analyses over clinical samples from ventilated critically ill patients could be a fast and secure alternative to conventional microbiological diagnostic methods in the identification of human pathogenic microbes in the setting of health care-acquired pneumonia. Therefore aspiration samples from intubated and ventilated critically ill patients, which are suspected to develop such an infection, will be collected and cultivated for a short period of time. The headspace over these cultures will be analyzed using MCC-IMS - a technology that allows on time detection and identification of very small amounts of substances in complex and humid gas samples. Conventional microbiological investigations, including MALDI-TOF, will be carried out parallel to the MCC-IMS analyses.

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Organizational Data

  •   DRKS00004178
  •   2012/06/20
  •   2012/06/08
  •   yes
  •   Approved
  •   1/7/06, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

  •   NCT01624181  (ClinicalTrials.gov)
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Health Condition or Problem studied

  •   J18 -  Pneumonia, organism unspecified
  •   J22 -  Unspecified acute lower respiratory infection
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Interventions/Observational Groups

  •   Patients will not be divided into groups. For each patient MCC-IMS analyses will be provided in addition to the conventional microbiological methods.
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Characteristics

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

identification of the pathogenic through MCC-IMS (multi-capillary column coupled ion mobility spectrometry)

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Secondary Outcome

faster identification through the use of MCC-IMS

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/06/25
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

1.) The patient has been hospitalized more than 48 hours ago. 2.) The patient is intubated and ventilated 3.) Decision for microbiological investigation of respiratory aspirate was made at the suspicion for an infection of the lower respiratory tract.

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Exclusion Criteria

1.) The Patient has been hospitalized less than 48 hours ago. 2.) Suspicion for an infection with a germ belonging to risk class 3 and 4, according to the german law (BioStoffV and TRBA, e.g. Mycobacterium tuberculosis).

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Addresses

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    • Universitätsmedizin Göttingen Zentrum Anaesthesiologie, Rettungs- und Intensivmedizin
    • Mr.  Prof. Dr. med.  Michael  Quintel 
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen Zentrum Anaesthesiologie, Rettungs- und Intensivmedizin
    • Mr.  Dr. med.  Thorsten  Perl 
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen Zentrum Anaesthesiologie, Rettungs- und Intensivmedizin
    • Mr.  Dr. med.  Nils  Kunze 
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Wirtschaft und Technologie ZIM-Projekt KF2111207AK0
    • Scharnhorststraße 34-37
    • 10115  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/09/30
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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.