Pneumonia Clinical Trial
Official title:
Identification of Microbes Through Detection of Pathogen Specific DNA Using Multiplex PCR as a Point of Care Diagnostic Tool in the Setting of Pneumonia
Verified date | February 2014 |
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 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.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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) |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | University Medical Center Göttingen | Göttingen | Niedersachsen |
Lead Sponsor | Collaborator |
---|---|
University of Göttingen | Curetis AG, Holzgerlingen, Germany |
Germany,
Caliendo AM. Multiplex PCR and emerging technologies for the detection of respiratory pathogens. Clin Infect Dis. 2011 May;52 Suppl 4:S326-30. doi: 10.1093/cid/cir047. Review. — View Citation
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. Epub 2005 Oct 13. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 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 |
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