Pneumonia Clinical Trial
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
Verified date | January 2013 |
Source | University of Göttingen |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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) |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | University Medical Center Göttingen | Göttingen | Niedersachsen |
Lead Sponsor | Collaborator |
---|---|
University of Göttingen | 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 |
Germany,
Jünger 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. — View Citation
Perl T, Jünger 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | No |
Primary | 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). | No |
Secondary | length of ICU stay | total LOS ICU | time from ICU admission to ICU discharge of study patients (up to 12 months) | No |
Secondary | 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. | No |
Secondary | 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) | No |
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