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

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Acute Lower Respiratory Tract Infection

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.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Germany
  • Niedersachsen
    • Göttingen, Niedersachsen, Germany, 37075
      • University Medical Center Göttingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time until pathogen identification through conventional microbiological diagnostic methods	time from sampling until the availability of the results.	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 until pathogen identification through MCC-IMS	time from sampling until the availability of the results.	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of ICU stay	total LOS ICU	time from ICU admission to ICU discharge of study patients (up to 12 months)
Type and dosage of administered antibiotic therapy	name and dosage of the antibiotic therapeutic agents used to threat the infection	approximately 5 days. Starting with the day the samples are taken. Ending with the day on which the results microbiological test are made avaiable.
morbidity	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.	Starts for study patients with the ICU admission and ends two days after the start of the initial antibiotic therapy. (up to 12 Months)

Collaborators and Investigators

• Sponsor: University of Göttingen
• Collaborators: Universität Duisburg-Essen; German Federal Ministry of Economics and Technology; B&S Analytik GmbH, Dortmund, Germany; Korean Institute for Science and Technology in Europe, Saarbrücken, Germany
• Investigators: Study Director: Michael Quintel, Prof. Dr., University of Göttingen

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: June 8, 2012
• First Submitted That Met QC Criteria: June 19, 2012
• First Posted (Estimate): June 20, 2012

Study Record Updates

• Last Update Posted (Estimate): January 10, 2013
• Last Update Submitted That Met QC Criteria: January 9, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: intensive care; hospital-acquired pneumonia; microbiological investigation; ion mobility spectrometry
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Respiratory Tract Infections
• Other Study ID Numbers: ZIM-KF2111207AK0; DRKS00004178 (Registry Identifier: German Clinical Trials Register)