Clinical trial NCT01624181: Fast Identification of Pathogen in the Setting of Hospital-acquired Pneumonia Using Ion Mobility Spectrometry
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lower Respiratory Tract Infection
Pneumonia
Keywords: ion mobility spectrometry
hospital-acquired pneumonia
microbiological investigation
intensive care
Lead sponsor: University of Göttingen
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Economics and Technology
name: B&S Analytik GmbH, Dortmund, Germany
name: Universität Duisburg-Essen
name: Korean Institute for Science and Technology in Europe, Saarbrücken, Germany
First posted: 2012-06-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients will be recruited from two intensive care units of the university hospital.

Brief summary: 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.

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 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)

Primary outcomes:
measure: Time until pathogen identification through MCC-IMS
timeFrame: 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).
measure: time until pathogen identification through conventional microbiological diagnostic methods
timeFrame: 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).
Secondary outcomes:
measure: length of ICU stay
timeFrame: time from ICU admission to ICU discharge of study patients (up to 12 months)
measure: Type and dosage of administered antibiotic therapy
timeFrame: approximately 5 days. Starting with the day the samples are taken. Ending with the day on which the results microbiological test are made avaiable.
measure: morbidity
timeFrame: Starts for study patients with the ICU admission and ends two days after the start of the initial antibiotic therapy. (up to 12 Months)
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Center Göttingen
state: Niedersachsen
Study officials:
affiliation: University of Göttingen
name: Michael Quintel, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Junger M, Vautz W, Kuhns M, Hofmann L, Ulbricht S, Baumbach JI, Quintel M, Perl T. Ion mobility spectrometry for microbial volatile organic compounds: a new identification tool for human pathogenic bacteria. Appl Microbiol Biotechnol. 2012 Mar;93(6):2603-14. doi: 10.1007/s00253-012-3924-4. Epub 2012 Feb 12.
citation: Perl T, Junger M, Vautz W, Nolte J, Kuhns M, Borg-von Zepelin M, Quintel M. Detection of characteristic metabolites of Aspergillus fumigatus and Candida species using ion mobility spectrometry-metabolic profiling by volatile organic compounds. Mycoses. 2011 Nov;54(6):e828-37. doi: 10.1111/j.1439-0507.2011.02037.x. Epub 2011 Jun 12.