DNA-based Testing in BAL of Lung Transplant Recipients With Suspected Non-viral Lower Respiratory Tract Infection
- Conditions
- Lower Respiratory Tract and Lung Infections
- Registration Number
- NCT02568358
- Lead Sponsor
- Hannover Medical School
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 48
- patients after lung transplantation (single, double or combined)
- suspicion of non-viral lower respiratory tract infection as defined by at least 2 out of
- new onset of malaise
- new or progressive pulmonary infiltrate
- hypoxemia (SpO2/SaO2 <92% or need for oxygen)
- temperature of 38 o C or above within 7 days
- purulent (yellow or greenish) sputum
- CRP of 30 mg/l or above
- PCT of 0,5 µg/l or above
- no informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method