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NCT Number: NCT01624181

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

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.

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Key information

Conditions

Acute Lower Respiratory Tract Infection Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Göttingen

Göttingen, Lower Saxony, 37075, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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).

    time from sampling until the availability of the results.

  2. 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).

    time from sampling until the availability of the results.

Secondary outcomes

  1. length of ICU stay

    Time frame: time from ICU admission to ICU discharge of study patients (up to 12 months)

    total LOS ICU

  2. 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.

    name and dosage of the antibiotic therapeutic agents used to threat the infection

  3. 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)

    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.

Sponsors and collaborators

Lead sponsor

University of Göttingen

Other

Collaborators

  • B&S Analytik GmbH, Dortmund, Germany
  • German Federal Ministry of Economics and Technology
  • Korean Institute for Science and Technology in Europe, Saarbrücken, Germany
  • Universität Duisburg-Essen

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 20, 2012
Registry last updated
Jan 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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