DNA-based Testing in BAL of Lung Transplant Recipients With Suspected Non-viral Lower Respiratory Tract Infection
|ClinicalTrials.gov Identifier: NCT02568358|
Recruitment Status : Unknown
Verified October 2015 by Thomas Fuehner, Hannover Medical School.
Recruitment status was: Not yet recruiting
First Posted : October 5, 2015
Last Update Posted : October 5, 2015
Lung transplantation (LTx) , DNA-based testing.
Performance of DNA-based testing of bacterial and fungal pathogens in comparison to standard testing.
Experimental intervention: DNA-based testing of BAL fluid.
|Condition or disease||Intervention/treatment|
|Lower Respiratory Tract and Lung Infections||Other: Experimental Intervention: DNA-based testing of BAL fluid|
|Study Type :||Observational|
|Estimated Enrollment :||48 participants|
|Official Title:||DNA-based Testing in BAL of Lung Transplant Recipients With Suspected Non-viral Lower Respiratory Tract Infection|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||June 2016|
- Other: Experimental Intervention: DNA-based testing of BAL fluid
DNA based testing needs 4.5 hours lab time in addition to standard testing
- Cohen's kappa of any pathogen isolation by DNA-based testing vs. standard cultures in comparison to the final diagnosis of non-viral lower respiratory tract infection [ Time Frame: 6 month ]Cohen's kappa measures the agreement between methods and the final clinical diagnosis. Both methods (DNA-based testing and standard cultures) will result in isolation of a non-viral pathogen or no isolation of a pathogen. A final clinical diagnosis will classify patients clinically in two categories as non-viral lower respiratory tract infection or no non-viral lower respiratory tract infection usually made 48-72 hours made after sampling. Cohen's kappa will be compared between the two methods.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568358
|Contact: Nora Drick, MD||0511 532 ext firstname.lastname@example.org|
|Contact: Hoyer Susanne||0511 532 ext email@example.com|
|Principal Investigator:||Jens Gottlieb, Prof. Dr.||Hannover Medical School|