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Fast Identification of Pathogen in the Setting of Hospital-acquired Pneumonia Using Ion Mobility Spectrometry

This study has been completed.
Sponsor:
Collaborators:
German Federal Ministry of Economics and Technology
B&S Analytik GmbH, Dortmund, Germany
University Duiburg-Essen, Institute for analytical chemistry
Korean Institute for Science and Technology in Europe, Saarbrücken, Germany
Information provided by (Responsible Party):
Dr. T. Perl, University of Göttingen
ClinicalTrials.gov Identifier:
NCT01624181
First received: June 8, 2012
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

With this study the investigators want to determine, if a fast identification of germs, causing hospital-acquired infections of the lower respiratory tract, is possible through the use of MCC-IMS technology - 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. The investigators want to determine 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.


Condition
Acute Lower Respiratory Tract Infection
Pneumonia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by University of Göttingen:

Primary Outcome Measures:
  • Time until pathogen identification through MCC-IMS [ Time Frame: Up to 24 hours after sampling. Sampling (as an iclusion criterion) can be necessary anytime along the ICU stay of the patient (up to 12 months). ] [ Designated as safety issue: No ]
    time from sampling until the availability of the results.

  • time until pathogen identification through conventional microbiological diagnostic methods [ Time Frame: Up to 5 days after Sampling. Sampling (as an iclusion criterion) can be necessary anytime along the ICU stay of the patient (up to 12 months). ] [ Designated as safety issue: No ]
    time from sampling until the availability of the results.


Secondary Outcome Measures:
  • length of ICU stay [ Time Frame: time from ICU admission to ICU discharge of study patients (up to 12 months) ] [ Designated as safety issue: No ]
    total LOS ICU

  • Type and dosage of administered antibiotic therapy [ Time Frame: approximately 5 days. Starting with the day the samples are taken. Ending with the day on which the results microbiological test are made avaiable. ] [ Designated as safety issue: No ]
    name and dosage of the antibiotic therapeutic agents used to threat the infection

  • morbidity [ Time Frame: Starts for study patients with the ICU admission and ends two days after the start of the initial antibiotic therapy. (up to 12 Months) ] [ Designated as safety issue: No ]
    morbidity of the critical ill patient at ICU admission, at the time of sampling and after two days of antibiotic therapy using the SAPS II scoring system.


Biospecimen Retention:   Samples Without DNA

aspiration samples from the respiratory system (tracheal secretion sample, BAL)


Enrollment: 24
Study Start Date: June 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Detailed Description:

In this clinical feasibility study it is to be investigated 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 hospital-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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients will be recruited from two intensive care units of the university hospital.

Criteria

Inclusion Criteria:

  • patient is at the hospital for more than 48 hours
  • patient is intubated and mechanically ventilated
  • clinical suspicion for an infection of the lower respiratory tract has been raised and decision for microbiological investigation of respiratory aspirate was made

Exclusion Criteria:

  • patient is at the hospital for less than 48 hours
  • patient has been recruited for another clinical study
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624181

Locations
Germany
University Medical Center Göttingen
Göttingen, Niedersachsen, Germany, 37075
Sponsors and Collaborators
University of Göttingen
German Federal Ministry of Economics and Technology
B&S Analytik GmbH, Dortmund, Germany
University Duiburg-Essen, Institute for analytical chemistry
Korean Institute for Science and Technology in Europe, Saarbrücken, Germany
Investigators
Study Director: Michael Quintel, Prof. Dr. University of Göttingen
  More Information

Additional Information:
Publications:
Responsible Party: Dr. T. Perl, Principal Investigator, University of Göttingen
ClinicalTrials.gov Identifier: NCT01624181     History of Changes
Other Study ID Numbers: ZIM-KF2111207AK0, DRKS00004178
Study First Received: June 8, 2012
Last Updated: January 9, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University of Göttingen:
ion mobility spectrometry
hospital-acquired pneumonia
microbiological investigation
intensive care

Additional relevant MeSH terms:
Pneumonia
Respiratory Tract Infections
Infection
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014