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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00004178 | Registry Identifier | German Clinical Trials Register |
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| Name | Class |
|---|---|
| German Federal Ministry of Economics and Technology | OTHER_GOV |
| B&S Analytik GmbH, Dortmund, Germany | UNKNOWN |
| Universität Duisburg-Essen | OTHER |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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patients will be recruited from two intensive care units of the university hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Quintel, Prof. Dr. | University of Göttingen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Göttingen | Göttingen | Lower Saxony | 37075 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22327321 | Background | 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. | |
| 21668516 | Background |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D000077299 | Healthcare-Associated Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Korean Institute for Science and Technology in Europe, Saarbrücken, Germany |
| UNKNOWN |
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aspiration samples from the respiratory system (tracheal secretion sample, BAL)
| 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) |
| 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. |
| D003428 |
| Cross Infection |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |