Acute Lower Respiratory Tract Infection, Pneumonia
Conditions
Keywords
multiplex PCR, MALDI-TOF, pneumonia, microbiological investigation, intensive care
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Curetis AG, Holzgerlingen, Germany
University of Göttingen
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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 has been recruited for a interventional clinical trial * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time until pathogen identification through Multiplex PCR | 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 from sampling until the availability of the results. |
| time until pathogen identification through conventional microbiological diagnostic methods | 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 from sampling until the availability of the results. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| length of ICU stay | time from ICU admission to ICU discharge of study patients (up to 12 months) | total LOS ICU |
| Type and dosage of administered antibiotic therapy | approximately 5 days. Starting with the day the samples are taken. Ending with the day on which the results microbiological test are made avaiable. | name and dosage of the antibiotic therapeutic agents used to threat the infection |
Countries
Germany
Outcome results
None listed