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| Name | Class |
|---|---|
| Curetis AG, Holzgerlingen, Germany | UNKNOWN |
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With this study the investigators want to determine, if a fast identification of germs, causing infections of the lower respiratory tract, is possible through the use of Multiplex PCR technology - a method that allows on time detection of bacteria in medical specimen by identifying DNA sequences that are known to be specific for the respective microbe. Therefore aspiration samples from the respiratory tracts of ventilated patients, which are suspected to develop such an infection, will be collected and analyzed by using a multiplex PCR (polymerase chain reaction) application situated on the intensive care unit. The investigators want to determine if Multiplex PCR diagnostic could be a faster alternative to conventional microbiological methods. The results of the Multiplex PCR analyses therefore will be compared with results of conventional microbiological methods.
In this clinical observational study it is to be investigated if Multiplex PCR analyses of clinical samples from ventilated critically ill patients could be a fast and accurate alternative to conventional microbiological diagnostic methods in the identification of human pathogenic microbes in the setting of pneumonia. Therefore aspiration samples from intubated and ventilated critically ill patients, which are suspected to develop such an infection, will be collected and analyzed by using a multiplex PCR application situated on the intensive care unit. The samples will be investigated for DNA sequences that are known to be specific for pneumonia causing microbes. Analyses will take place in a point of care setting and will be carried out by intensive care physicians. According to the standard protocols of our intensive care units, conventional microbiological investigations, including MALDI-TOF, will be carried out parallel to the Multiplex PCR analyses.
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| Measure | Description | Time Frame |
|---|---|---|
| Time until pathogen identification through Multiplex PCR | 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 |
|---|---|---|---|
| 16231254 | Background | Oosterheert JJ, van Loon AM, Schuurman R, Hoepelman AI, Hak E, Thijsen S, Nossent G, Schneider MM, Hustinx WM, Bonten MJ. Impact of rapid detection of viral and atypical bacterial pathogens by real-time polymerase chain reaction for patients with lower respiratory tract infection. Clin Infect Dis. 2005 Nov 15;41(10):1438-44. doi: 10.1086/497134. Epub 2005 Oct 13. | |
| 21460291 |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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aspiration samples from the respiratory system (tracheal secretion sample, BAL) containing microbial DNA
| approximately 5 days. Starting with the day the samples are taken. Ending with the day on which the results microbiological test are made avaiable. |
| Caliendo AM. Multiplex PCR and emerging technologies for the detection of respiratory pathogens. Clin Infect Dis. 2011 May;52 Suppl 4(Suppl 4):S326-30. doi: 10.1093/cid/cir047. |
| 26071191 | Derived | Kunze N, Moerer O, Steinmetz N, Schulze MH, Quintel M, Perl T. Point-of-care multiplex PCR promises short turnaround times for microbial testing in hospital-acquired pneumonia--an observational pilot study in critical ill patients. Ann Clin Microbiol Antimicrob. 2015 Jun 13;14:33. doi: 10.1186/s12941-015-0091-3. |